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Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) (NO FEAR-BE)

Primary Purpose

Barrett Esophagus, Intestinal Metaplasia, Esophageal Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CryoBalloon Focal Ablation System
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett Esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of BE with LGD or HGD confirmed with biopsy, or resected intramucosal cancer (IMC) with low risk of recurrence defined as EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
  2. Prior treatment with RFA who meet either of the following criteria at the enrolling EGD:

    2.1. History of at least 3 RFA treatments, with one or more of the following:

    • 2.1.1. Residual BE Prague >=C1
    • 2.1.2. Residual BE >=M1
    • 2.1.3. One or more islands of residual BE >1 cm in diameter
    • 2.1.4. Any residual dysplasia in tubular esophagus 2.2. History of at least 2 RFA treatments and < 50% eradication of BE, as judged by estimation of the treating physician.
  3. 18 or older years of age at time of consent.
  4. Provides written informed consent.
  5. Willing to undergo an alternative approved standard of care treatment for their condition.
  6. Willing and able to comply with study requirements for follow-up.
  7. No prior history of balloon or spray cryotherapy esophageal treatment. Prior APC is allowable.

Exclusion Criteria:

  1. Residual BE Prague length measuring >C3 or >M8 after RFA treatment.
  2. Dysplasia or IM confined only to the gastric cardia (BE Prague C0M0).
  3. Pre-existing esophageal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline EGD. Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed per protocol.
  4. Symptomatic, untreated esophageal strictures.
  5. Any endoscopically-visualized abnormalities such as ulcers, masses or nodules during screening/baseline EGD. Subjects with nodular dysplasia or IMC identified during screening/baseline EGD may be treated with EMR or ESD and return for baseline treatment in this study at least 6 weeks later given that:

    5.1. Follow-up endoscopy must be negative for nodular dysplasia (visually clear of nodular dysplasia).

    5.2. Patients with IMC must be at low risk for recurrence, confirmed by EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.

  6. EMR or ESD < 6 weeks prior to baseline treatment.
  7. Untreated invasive esophageal malignancy, including margin-positive EMR/ESD.
  8. Active reflux esophagitis grade B or higher assessed during screening/baseline EGD.
  9. Severe medical comorbidities precluding endoscopy or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
  10. Uncontrolled coagulopathy.
  11. Inability to hold use of anti-coagulation medications or non-aspirin anti-platelet agents (APAs) for the duration recommended per ASGE guidelines for a high-risk endoscopy procedure.
  12. Active fungal esophagitis.
  13. Known portal hypertension, visible esophageal varices, or history of esophageal varices.
  14. General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
  15. Pregnant or planning to become pregnant during period of study participation.
  16. Patient refuses or is unable to provide written informed consent.
  17. Prior esophageal surgery with the exception of uncomplicated nissen fundoplication.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Georgetown UniversityRecruiting
  • Johns Hopkins UniversityRecruiting
  • Mayo Clinic RochesterRecruiting
  • Northwell HealthRecruiting
  • Icahn School of Medicine at Mount Sinai
  • Columbia UniversityRecruiting
  • UNC Chapel HillRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Geisinger ClinicRecruiting
  • Medical University of South CarolinaRecruiting
  • UTHealth Science Center/Herman MemorialRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryoballoon Focal Ablation System (CbFAS) Treatment

Arm Description

Subjects undergoing CbFAS treatment as part of their clinical care for their condition.

Outcomes

Primary Outcome Measures

Percentage of all treated Subjects with complete eradication of all intestinal metaplasia (CEIM) within 12 months of enrollment.
Percentage of all treated subjects with complete eradication of dysplasia (CED) within 12 months of enrollment
Stratified by prior type of ablation treatment and baseline grade (LGD or HGD) will also be reported.
Incidence of CryoBalloon-related serious adverse events
Relation of serious adverse events to CryoBalloon device will be assessed by the PI

Secondary Outcome Measures

Technical success rate
The device worked as expected on every application, defined as proportion of all CbFAS that perform as intended.
Procedure success rate
All columnar tissue that was planned to be treated was treated.
Progression rate
Percentage of subjects with progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer at 12 months from enrollment date.
Survival curve analysis - time to CEIM
Time to complete eradication of intestinal metaplasia (CEIM). Survival curve analysis from first treatment.
Survival curve analysis - time to progression
Time to progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer at 12 months from enrollment date. Survival curve analysis from first treatment.
Survival curve analysis - time to recurrence
Time to recurrence. Survival curve analysis from first treatment.
Risk factors associated with failure to respond to CryoBalloon ablation
Risk factors associated with failure to respond to CryoBalloon ablation
Median number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Median number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Mean number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Mean number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Proportion of subjects requiring narcotic analgesic - Day 1
Proportion of subjects requiring narcotic analgesic at day 1 post treatment.
Proportion of subjects requiring narcotic analgesic - Day 7
Proportion of subjects requiring narcotic analgesic at day 7 post treatment.
Proportion of subjects requiring narcotic analgesic - Day 30
Proportion of subjects requiring narcotic analgesic at day 30 post treatment.
Median pain score - Day 1
Median pain score immediately post-procedure day 1 as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Median pain score - Day 7
Median pain score 7 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Median pain score - Day 30
Median pain score 30 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Mean pain score - Day 1
Mean pain score immediately post-procedure day 1 as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Mean pain score - Day 7
Mean pain score 7 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Mean pain score - Day 30
Mean pain score 30 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Proportion of Barrett's Esophagus surface area reverted to neosquamous epithelium
For those who do not achieve CEIM and CED at 12 months from enrollment date, proportion of Barrett's Esophagus surface area reverted to neosquamous epithelium based on physician report.

Full Information

First Posted
May 30, 2018
Last Updated
October 3, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
PENTAX of America, Inc., Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03554356
Brief Title
Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)
Acronym
NO FEAR-BE
Official Title
Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
PENTAX of America, Inc., Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A multicenter, prospective, single arm, non randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments.
Detailed Description
Eligibility will be determined based on historical local pathology and medical record information. Informed consent will be obtained and eligible subjects will be treated with the Cryoballoon Focal Ablation System (CbFAS) at baseline. Subjects will return every 3 months +/- 6 weeks for repeat treatment for up to 12 months OR until complete eradication of intestinal metaplasia (CEIM) and complete eradication of dysplasia (CED) are achieved (at which point subjects enter the follow-up phase), whichever occurs first. Treatment procedures will be performed on an outpatient basis according to the site's standards of care for anesthesia and sedation during esophagogastroduodenoscopy (EGD) procedures. EGD examinations will be performed using high definition White Light Endoscopy (WLE), plus Narrow Band Imaging (NBI) or i-SCAN to assess BE Prague Score and identify tissue landmarks and ablation zones. A high definition endoscope will be used for all ablations performed with the CryoBalloon Focal Ablation System (CbFAS). The System will be used according to the instructions for use provided with the product and in accordance with the current standard of care for treatment of BE. Repeat cryoablation may be performed if esophageal columnar mucosa is visible on EGD or if intervening biopsies (if a site chooses to obtain intervening biopsies as standard of care) are positive for any esophageal columnar epithelium until complete eradication of all unwanted tissue is achieved. Intervening endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) after enrollment may be performed for nodular areas detected after baseline. EMR/ESD may be performed at the same session as the cryoablation if the EMR/ESD site is >=3cm away from the ablation target site. Cryoablation should be performed before EMR/ESD. If the EMR/ESD site is within 3cm of target treatment area, then CbFAS will be delayed for at least 6 weeks. Residual islands of columnar mucosa of <5 mm in diameter each and <= 3 total can be treated with Argon Plasma Coagulation (APC) and/or CbFAS at the discretion of the treating physician to avoid over treatment of neo-squamous mucosa. Stenosis requiring treatment based on the physician's discretion, which develops after enrollment, will be treated with standard of care balloon- or wire-guided dilation. Cryoablation may be performed at the same session if the dilated site is >= 3 cm from the target cryoablation site. Otherwise, cryoablation will be postponed to another visit within 1 month +/- 2 weeks. When CbFAS treatment is received, subjects will be asked to complete assessments immediately after CbFAS treatment, and will be contacted 1 day, 7 days, and 30 days after the procedure. If no visible BE is present during the endoscopy, then biopsies will be taken following the standard Seattle biopsy protocol (4 quadrant biopsies at 1cm intervals starting at the gastric cardia 1cm distal to the gastroesophageal junction (GEJ) (top of the gastric folds) and continuing proximally throughout the length of the original extent of BE, including any neosquamous or re-epithelialized tissue). Biopsies will be read by local expert pathologist. If biopsies indicate CEIM and CED, then subjects will enter the 12 month follow-up phase. If biopsies do not indicate CEIM and CED, then subjects will return for additional CbFAS treatment in 3 months +/-6 weeks. Non-responders are defined as subjects who have not achieved CEIM and CED at 12 months post baseline CbFAS treatment. Non-responders at 12 months will exit the study and continue treatment at the physician's discretion and according to standard of care at each site. Subjects who achieve CEIM and CED within 12 months of the baseline CbFAS procedure will enter a 12 month follow-up phase. Subjects will be followed per routine care guidelines for their condition, described below: Subjects with baseline LGD will return at 6 and 12 months from the initial CEIM and CED date for follow-up (+/-2 weeks). Subjects with baseline HGD or IMC will return at 3, 6, 9, and 12 months from initial CEIM and CED date for follow-up (+/- 2 weeks). During follow-up procedures, high definition WLE, plus NBI or i-SCAN will be used to assess Prague score, and biopsies will be taken following the standard Seattle biopsy protocol (4 quadrant biopsies at 1cm intervals starting at the gastric cardia 1cm distal to the gastroesophageal junction (GEJ) (top of the gastric folds) and continuing proximally throughout the length of the original extent of BE, including any neosquamous or re-epithelialized tissue). Biopsies will be read by local expert pathologist. If recurrent BE is detected during follow-up endoscopy with biopsy demonstrating compatible histology, then subjects will be exited from the study and treated at the physician's discretion. Study participation is complete if: 1) Subject has not reached CEIM and CED at 12 month post baseline treatment; or 2) If BE or dysplasia recur after initial CEIM and CED post enrollment; or 3) After completion of the 12 month follow-up EGD with biopsies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, Intestinal Metaplasia, Esophageal Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryoballoon Focal Ablation System (CbFAS) Treatment
Arm Type
Experimental
Arm Description
Subjects undergoing CbFAS treatment as part of their clinical care for their condition.
Intervention Type
Device
Intervention Name(s)
CryoBalloon Focal Ablation System
Intervention Description
CryoBalloon Focal Ablation System
Primary Outcome Measure Information:
Title
Percentage of all treated Subjects with complete eradication of all intestinal metaplasia (CEIM) within 12 months of enrollment.
Time Frame
12 months
Title
Percentage of all treated subjects with complete eradication of dysplasia (CED) within 12 months of enrollment
Description
Stratified by prior type of ablation treatment and baseline grade (LGD or HGD) will also be reported.
Time Frame
12 months
Title
Incidence of CryoBalloon-related serious adverse events
Description
Relation of serious adverse events to CryoBalloon device will be assessed by the PI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technical success rate
Description
The device worked as expected on every application, defined as proportion of all CbFAS that perform as intended.
Time Frame
At end of treatment period, up to 12 months
Title
Procedure success rate
Description
All columnar tissue that was planned to be treated was treated.
Time Frame
At end of treatment period, up to 12 months
Title
Progression rate
Description
Percentage of subjects with progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer at 12 months from enrollment date.
Time Frame
At end of treatment period, up to 12 months
Title
Survival curve analysis - time to CEIM
Description
Time to complete eradication of intestinal metaplasia (CEIM). Survival curve analysis from first treatment.
Time Frame
At end of treatment period, up to 12 months
Title
Survival curve analysis - time to progression
Description
Time to progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer at 12 months from enrollment date. Survival curve analysis from first treatment.
Time Frame
At end of treatment period, up to 12 months
Title
Survival curve analysis - time to recurrence
Description
Time to recurrence. Survival curve analysis from first treatment.
Time Frame
At end of treatment period, up to 12 months
Title
Risk factors associated with failure to respond to CryoBalloon ablation
Description
Risk factors associated with failure to respond to CryoBalloon ablation
Time Frame
At end of treatment period, up to 12 months
Title
Median number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Description
Median number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Time Frame
At end of treatment period, up to 12 months
Title
Mean number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Description
Mean number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.
Time Frame
At end of treatment period, up to 12 months
Title
Proportion of subjects requiring narcotic analgesic - Day 1
Description
Proportion of subjects requiring narcotic analgesic at day 1 post treatment.
Time Frame
Day 1
Title
Proportion of subjects requiring narcotic analgesic - Day 7
Description
Proportion of subjects requiring narcotic analgesic at day 7 post treatment.
Time Frame
Day 7
Title
Proportion of subjects requiring narcotic analgesic - Day 30
Description
Proportion of subjects requiring narcotic analgesic at day 30 post treatment.
Time Frame
Day 30
Title
Median pain score - Day 1
Description
Median pain score immediately post-procedure day 1 as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Time Frame
Day 1
Title
Median pain score - Day 7
Description
Median pain score 7 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Time Frame
Day 7
Title
Median pain score - Day 30
Description
Median pain score 30 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Time Frame
Day 30
Title
Mean pain score - Day 1
Description
Mean pain score immediately post-procedure day 1 as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Time Frame
Day 1
Title
Mean pain score - Day 7
Description
Mean pain score 7 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Time Frame
Day 7
Title
Mean pain score - Day 30
Description
Mean pain score 30 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.
Time Frame
Day 30
Title
Proportion of Barrett's Esophagus surface area reverted to neosquamous epithelium
Description
For those who do not achieve CEIM and CED at 12 months from enrollment date, proportion of Barrett's Esophagus surface area reverted to neosquamous epithelium based on physician report.
Time Frame
At end of treatment period, up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of BE with LGD or HGD confirmed with biopsy, or resected intramucosal cancer (IMC) with low risk of recurrence defined as EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion. Prior treatment with RFA who meet either of the following criteria at the enrolling EGD: 2.1. History of at least 3 RFA treatments, with one or more of the following: 2.1.1. Residual BE Prague >=C1 2.1.2. Residual BE >=M1 2.1.3. One or more islands of residual BE >=1 cm in diameter 2.1.4. Any residual dysplasia in tubular esophagus 2.2. History of at least 2 RFA treatments and < 50% eradication of BE, as judged by estimation of the treating physician. 18 or older years of age at time of consent. Provides written informed consent. Willing to undergo an alternative approved standard of care treatment for their condition. Willing and able to comply with study requirements for follow-up. No prior history of balloon or spray cryotherapy esophageal treatment. Prior APC is allowable. Exclusion Criteria: Residual BE Prague length measuring >C3 or >M8 after RFA treatment. Dysplasia or IM confined only to the gastric cardia (BE Prague C0M0). Pre-existing esophageal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline EGD. Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed per protocol. Symptomatic, untreated esophageal strictures. Any endoscopically-visualized abnormalities such as ulcers, masses or nodules during screening/baseline EGD. Subjects with nodular dysplasia or IMC identified during screening/baseline EGD may be treated with EMR or ESD and return for baseline treatment in this study at least 6 weeks later given that: 5.1. Follow-up endoscopy must be negative for nodular dysplasia (visually clear of nodular dysplasia). 5.2. Patients with IMC must be at low risk for recurrence, confirmed by EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion. EMR or ESD < 6 weeks prior to baseline treatment. Untreated invasive esophageal malignancy, including margin-positive EMR/ESD. Active reflux esophagitis grade B or higher assessed during screening/baseline EGD. Severe medical comorbidities precluding endoscopy or limiting life expectancy to less than 2 years in the judgment of the endoscopist. Uncontrolled coagulopathy. Inability to hold use of anti-coagulation medications or non-aspirin anti-platelet agents (APAs) for the duration recommended per ASGE guidelines for a high-risk endoscopy procedure. Active fungal esophagitis. Known portal hypertension, visible esophageal varices, or history of esophageal varices. General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation. Pregnant or planning to become pregnant during period of study participation. Patient refuses or is unable to provide written informed consent. Prior esophageal surgery with the exception of uncomplicated nissen fundoplication.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Cortright, MA
Phone
919-445-4911
Email
lindsay_cortright@med.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Moist, MPH
Phone
919-918-5900
Email
susan_moist@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas J Shaheeen, MD, MPH
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alesha Matthews
Email
aleshamatthews@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Shajan Peter, MD
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keval Thakkar
Email
keval.v.thakkar@medstar.net
First Name & Middle Initial & Last Name & Degree
Farhat Ahmed
Email
farhat.ahmed@medstar.net
First Name & Middle Initial & Last Name & Degree
Shervin Shafa, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilary Cosby
Email
hcosby1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Marcia Canto, MD
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramona Lansing, RN
Email
Lansing.Ramona@mayo.edu
First Name & Middle Initial & Last Name & Degree
Melissa Passe
Email
passe.melissa@mayo.edu
First Name & Middle Initial & Last Name & Degree
Prasad Iyer, MD
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Stewart
Email
mstewart8@northwell.edu
First Name & Middle Initial & Last Name & Degree
Victoria Barone
Email
vbarone1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Arvind Trindade, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Cohen
Email
michele.cohen@mssm.edu
First Name & Middle Initial & Last Name & Degree
Michael Smith, MD
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharine Boyce
Email
kb3217@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Rowena Fang
Email
rf2808@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Julian Abrams, MD
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Kim
Phone
919-843-3946
Email
julia_kim@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Shilpa Karanjit
Email
shilpa_karanjit@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Nicholas J Shaheen, MD, MPH
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Brock
Email
Wendy.Brock@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Amitabh Chak, MD
First Name & Middle Initial & Last Name & Degree
John Dumot, MD
Facility Name
Geisinger Clinic
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolas Antinnes
Phone
570-214-5180
Email
nantinnes@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Harshit Khara, MD
First Name & Middle Initial & Last Name & Degree
David Diehl, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayisa Wright
Phone
843-792-2375
Email
kcw202@musc.edu
First Name & Middle Initial & Last Name & Degree
Ashley Warden
Email
jonesash@musc.edu
First Name & Middle Initial & Last Name & Degree
Puja Sukwhani Elias
First Name & Middle Initial & Last Name & Degree
Brenda Hoffman
Facility Name
UTHealth Science Center/Herman Memorial
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghna Yammanur
Email
Chaitanya.S.Yammanur@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Angie Rivera
Email
angielyn.r.rivera@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Nirav Thosani, MD

12. IPD Sharing Statement

Learn more about this trial

Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)

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