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Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System (ColdPlayIII)

Primary Purpose

Barrett Esophagus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CryoBalloon Ablation System
Sponsored by
Pentax Medical
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:

  • Low- or high-grade non-nodular, previously untreated ("treatment naïve") dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ≥6 weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.
  • BE length ≤6cm excluding visible BE islands, and Prague Classification C ≥0 / M ≥1
  • Older than 18 years of age at time of consent
  • Operable per institution's standards
  • Provides written informed consent on the approved informed consent form
  • Willing and able to comply with study requirements for follow-up

Exclusion Criteria:

  • Non-dysplastic or indefinite for dysplasia BE, confirmed by histopathological analysis
  • Esophageal stenosis/stricture preventing advancement of a therapeutic endoscope (patients may have the stenosis/stricture dilated and then be treated with CryoBalloon ablation under this protocol at a subsequent procedure ≥2 weeks later)
  • Symptomatic untreated strictures
  • Any endoscopically-visualized abnormalities such as ulcers, masses or nodules. Neoplastic nodules must first be treated with EMR ≥6 weeks prior to planned treatment under this protocol.
  • History of esophageal cancer more extensive than T1a or not meeting criteria for low risk of recurrence (confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion)
  • History of esophageal varices
  • Large (>4cm) hiatal hernia
  • Prior distal esophagectomy
  • Any clinical or histological suspicion of esophageal adenocarcinoma invading into the submucosa by endoscopic mucosal resection (EMR), or confirmed T1a cancer with positive deep margin by EMR
  • Active esophagitis grade B or higher
  • Severe medical comorbidities precluding endoscopy
  • Uncontrolled coagulopathy
  • Pregnant or planning to become pregnant during period of study participation
  • Patient refuses or is unable to provide written informed consent
  • Life expectancy ≤3 years, as judged by the site investigator
  • General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

Sites / Locations

  • UC Irvine
  • Sarasota Memorial Hospital
  • University of Chicago
  • John Hopkins
  • Mayo Clinic
  • Northwell Health
  • New York Presbyterian Hospital-Columbia University Medical Center
  • University of North Carolina School of Medicine
  • University Hospitals Cleveland Medical Center
  • Geisinger Medical Center
  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CryoBalloon Ablation System

Arm Description

Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.

Outcomes

Primary Outcome Measures

Incidence of serious, CryoBalloon Ablation System-related adverse events
Percentage of patients with baseline LGD who have complete eradication of all dysplasia
percentage of patients with baseline HGD who have complete eradication of all dysplasia
percentage of all treated patients who have complete eradication of all dysplasia (CE-D)

Secondary Outcome Measures

Percentage of subjects with complete eradication of all esophageal intestinal metaplasia (CE-IM)
Percentage of subjects with progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer
For Baseline LGD and HGD subjects: progression of dysplasia
Incidence of all treatment-related and all serious, non-treatment-related adverse events
Incidence of post procedure chest discomfort events / Pain score >0 and <5
(scored on a 0-10 visual analog pain scale)
Incidence of post procedure chest discomfort events / Pain score ≥5 and requiring narcotic analgesic
(scored on a 0-10 visual analog pain scale)
Mean and Median Pain score on Day 1 post procedure
(scored on a 0-10 visual analog pain scale)
Mean and Median Pain score on Day 7 post procedure
(scored on a 0-10 visual analog pain scale)
Rate of (CE-D) and all esophageal (CE-IM) will be reported as a percentage of all subjects enrolled, and stratified by baseline dysplasia grade
Number of CryoBalloon ablation treatments required to achieve CE-D or CE-IM
(mean and median)

Full Information

First Posted
July 31, 2015
Last Updated
April 21, 2022
Sponsor
Pentax Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02514525
Brief Title
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
Acronym
ColdPlayIII
Official Title
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pentax Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)
Detailed Description
Coldplay III is a multi-center, prospective study that will provide evidence of the efficacy and safety of the System in treatment of patients with previously untreated (treatment naïve) low grade dysplasia (LGD) or high grade dysplasia (HGD) BE. Subjects may have a maximum of five (5) ablation treatment sessions during their 12 months of study participation to achieve complete eradication of their dysplastic BE and intestinal metaplasia. As many ablations as needed to treat the dysplastic areas are allowed in each treatment session at the discretion of the investigator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CryoBalloon Ablation System
Arm Type
Other
Arm Description
Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.
Intervention Type
Device
Intervention Name(s)
CryoBalloon Ablation System
Other Intervention Name(s)
CryoBalloon Focal Ablation System
Intervention Description
CryoBalloon Ablation System, a balloon-based cryotherapy device, provides controlled ablation for the treatment of BE. Deployed through the working channel of an endoscope, the Balloon is simultaneously inflated and cooled with an inert cryogen (nitrous oxide) delivered from the handle that ablates the BE cells upon contact with the esophagus.
Primary Outcome Measure Information:
Title
Incidence of serious, CryoBalloon Ablation System-related adverse events
Time Frame
12 months
Title
Percentage of patients with baseline LGD who have complete eradication of all dysplasia
Time Frame
12 months
Title
percentage of patients with baseline HGD who have complete eradication of all dysplasia
Time Frame
12 months
Title
percentage of all treated patients who have complete eradication of all dysplasia (CE-D)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of subjects with complete eradication of all esophageal intestinal metaplasia (CE-IM)
Time Frame
12 months
Title
Percentage of subjects with progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer
Description
For Baseline LGD and HGD subjects: progression of dysplasia
Time Frame
12 months
Title
Incidence of all treatment-related and all serious, non-treatment-related adverse events
Time Frame
12 months
Title
Incidence of post procedure chest discomfort events / Pain score >0 and <5
Description
(scored on a 0-10 visual analog pain scale)
Time Frame
Day 1
Title
Incidence of post procedure chest discomfort events / Pain score ≥5 and requiring narcotic analgesic
Description
(scored on a 0-10 visual analog pain scale)
Time Frame
Day 7
Title
Mean and Median Pain score on Day 1 post procedure
Description
(scored on a 0-10 visual analog pain scale)
Time Frame
Day 1
Title
Mean and Median Pain score on Day 7 post procedure
Description
(scored on a 0-10 visual analog pain scale)
Time Frame
Day 7
Title
Rate of (CE-D) and all esophageal (CE-IM) will be reported as a percentage of all subjects enrolled, and stratified by baseline dysplasia grade
Time Frame
24 and 36 months
Title
Number of CryoBalloon ablation treatments required to achieve CE-D or CE-IM
Description
(mean and median)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Low- or high-grade non-nodular, previously untreated ("treatment naïve") dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ≥6 weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion. BE length ≤6cm excluding visible BE islands, and Prague Classification C ≥0 / M ≥1 Older than 18 years of age at time of consent Operable per institution's standards Provides written informed consent on the approved informed consent form Willing and able to comply with study requirements for follow-up Exclusion Criteria: Non-dysplastic or indefinite for dysplasia BE, confirmed by histopathological analysis Esophageal stenosis/stricture preventing advancement of a therapeutic endoscope (patients may have the stenosis/stricture dilated and then be treated with CryoBalloon ablation under this protocol at a subsequent procedure ≥2 weeks later) Symptomatic untreated strictures Any endoscopically-visualized abnormalities such as ulcers, masses or nodules. Neoplastic nodules must first be treated with EMR ≥6 weeks prior to planned treatment under this protocol. History of esophageal cancer more extensive than T1a or not meeting criteria for low risk of recurrence (confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion) History of esophageal varices Large (>4cm) hiatal hernia Prior distal esophagectomy Any clinical or histological suspicion of esophageal adenocarcinoma invading into the submucosa by endoscopic mucosal resection (EMR), or confirmed T1a cancer with positive deep margin by EMR Active esophagitis grade B or higher Severe medical comorbidities precluding endoscopy Uncontrolled coagulopathy Pregnant or planning to become pregnant during period of study participation Patient refuses or is unable to provide written informed consent Life expectancy ≤3 years, as judged by the site investigator General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia Canto, MD
Organizational Affiliation
Johns Hopkins Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
John Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York Presbyterian Hospital-Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.
Citations:
PubMed Identifier
33156107
Citation
Canto MI, Trindade AJ, Abrams J, Rosenblum M, Dumot J, Chak A, Iyer P, Diehl D, Khara HS, Corbett FS, McKinley M, Shin EJ, Waxman I, Infantolino A, Tofani C, Samarasena J, Chang K, Wang B, Goldblum J, Voltaggio L, Montgomery E, Lightdale CJ, Shaheen NJ. Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-Related Neoplasia: A Prospective Multicenter Clinical Trial. Am J Gastroenterol. 2020 Nov;115(11):1879-1890. doi: 10.14309/ajg.0000000000000822.
Results Reference
derived

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Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System

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