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Endorotor Resection In Refractory Barrett's Dysplasia Patients

Primary Purpose

Barrett's Esophagus With Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
EndoRotor Mucosal Resection System
Continued Ablation
Sponsored by
Interscope, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett's Esophagus With Dysplasia

Eligibility Criteria

30 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects who are greater than 30 and less than 90 years of age; inclusive of males and females.
  2. Subjects with confirmed Barrett's esophagus with dysplasia (low-grade or high-grade) and meeting at least one of the following criteria:

    1. Failed 3 ablative procedures (RFA and/or Cryotherapy).
    2. Failed at least 1 ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-procedure dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.
  3. Residual Barrett's length is ≥1 cm and ≤6 cm.
  4. No confirmed evidence of esophageal adenocarcinoma (EAC) at the time of therapy.
  5. Subject capable of giving informed consent.
  6. Subject has a reasonable expectation for prolonged survival (greater than 2 years).
  7. Subject can tolerate repeated endoscopic procedures.
  8. Absence of strictures refractory to dilation that preclude the passage of the endoscope
  9. Patients who were on acid suppression therapy (i.e. PPIs) during the course of failed primary ablative therapy, and who can continue acid suppression therapy for the entire time they are on the clinical study.
  10. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 12 months, as indicated.

Exclusion Criteria:

  1. Subject unable to give informed consent.
  2. Subject is unwilling to return for repeated endoscopies.
  3. Confirmed endoscopic and or histologic evidence of EAC at time of therapy.
  4. Residual Barrett's longer than 6 cm.
  5. Subjects with nodular Barrett's esophagus.
  6. Subjects who are on anticoagulant therapy that cannot be discontinued for 5 days before and after the procedure.
  7. Subjects with known coagulopathy defined as abnormal prothrombin or partial thromboplastin time.
  8. History of esophageal varices
  9. LA Grade B, C, or D esophagitis.
  10. Esophageal stricture refractory to dilation preventing passage of endoscope or catheter.
  11. Any previous esophageal surgery, except fundoplication without complications.
  12. Medically uncorrectable hypotension or hypertension.
  13. Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
  14. Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
  15. Subject has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions.
  16. Patient has a known significant concomitant illness with a life expectancy of less than 2 years.
  17. Subject is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

Sites / Locations

  • The Mayo ClinicRecruiting
  • University of Rochester Medical CenterRecruiting
  • Sahlgrenska University HospitalRecruiting
  • NHS University College HospitalRecruiting
  • Nottingham University Hospitals NHS Trust and University of NottinghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EndoRotor Resection

Continued Ablation (Control)

Arm Description

For the purpose of this study the EndoRotor System is investigationally indicated for use during endoscopic procedures to resect and remove refractory Barrett's esophagus tissue in conjunction with a submucosal saline injection mix using adrenaline and dye. Subjects randomized to the EndoRotor arm will be treated up to 3 times through the 9 month follow-up period to remove gross visible Barrett's.

The investigator shall exercise standard of care for subjects undergoing continued ablative therapies (RFA and/or Cryotherapy). These will constitute the control devices. The investigator will choose the system in this arm. Operation of each system will be done according to the manufacturer's IFU. Subjects randomized to the control arm may be treated up to 3 time through the 9 month follow-up period to remove gross visible Barrett's.

Outcomes

Primary Outcome Measures

Incidence of complete removal of refractory Barrett's esophagus
The primary effectiveness endpoint for this study is the complete removal of refractory Barrett's esophagus in no more than three treatments as assessed by a biopsy negative for Barrett's esophagus at the 12 month follow-up visit.
Rate of device- and procedure-related serious adverse events (SAEs)
The primary safety endpoint for this study is the rate of device- and procedure-related serious adverse events (SAEs) for bleeding, perforation, and stricture in the EndoRotor arm will be no greater than that of the continued ablative therapy arm.

Secondary Outcome Measures

Activated Fibroblasts
Percent reduction of activated fibroblasts in the area with Barrett's esophagus that was resected using EndoRotor at initial treatment session through the 12 month follow-up visit as per the histological findings of keyhole technique biopsies. - this point is only assessed in the first 5 EndoRotor subjects
Percent Reduction of Barrett's Esophagus
Percent reduction of Barrett's esophagus that was resected or ablated during the initial treatment session through the 12 month follow-up visit as calculated using the Prague classification measurements of estimated circumference and maximal length.
Post Procedure Pain
Assessment of subject post procedure pain as compared to the control arm by means of a visual analogue pain scale. The visual analogue pain scale used for this study allows a patient to record their pain using a scoring system from 0 to 10. Zero representing no pain, 5 representing moderate pain, and 10 representing the worst possible pain. Lower scores represent a better score.

Full Information

First Posted
November 29, 2017
Last Updated
August 1, 2022
Sponsor
Interscope, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03364114
Brief Title
Endorotor Resection In Refractory Barrett's Dysplasia Patients
Official Title
Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Interscope, Inc.

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
The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.
Detailed Description
Prospective, multi-center, randomized controlled trial, pivotal, investigational device exemption (IDE) to compare the safety and performance of the EndoRotor® Mucosal Resection System with continued ablative therapy in subjects with refractory Barrett's Esophagus. The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus With Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EndoRotor Resection
Arm Type
Experimental
Arm Description
For the purpose of this study the EndoRotor System is investigationally indicated for use during endoscopic procedures to resect and remove refractory Barrett's esophagus tissue in conjunction with a submucosal saline injection mix using adrenaline and dye. Subjects randomized to the EndoRotor arm will be treated up to 3 times through the 9 month follow-up period to remove gross visible Barrett's.
Arm Title
Continued Ablation (Control)
Arm Type
Active Comparator
Arm Description
The investigator shall exercise standard of care for subjects undergoing continued ablative therapies (RFA and/or Cryotherapy). These will constitute the control devices. The investigator will choose the system in this arm. Operation of each system will be done according to the manufacturer's IFU. Subjects randomized to the control arm may be treated up to 3 time through the 9 month follow-up period to remove gross visible Barrett's.
Intervention Type
Device
Intervention Name(s)
EndoRotor Mucosal Resection System
Intervention Description
The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.
Intervention Type
Device
Intervention Name(s)
Continued Ablation
Intervention Description
Continued ablation control shall include either cryotherapy or continued radial frequency ablation.
Primary Outcome Measure Information:
Title
Incidence of complete removal of refractory Barrett's esophagus
Description
The primary effectiveness endpoint for this study is the complete removal of refractory Barrett's esophagus in no more than three treatments as assessed by a biopsy negative for Barrett's esophagus at the 12 month follow-up visit.
Time Frame
12 months
Title
Rate of device- and procedure-related serious adverse events (SAEs)
Description
The primary safety endpoint for this study is the rate of device- and procedure-related serious adverse events (SAEs) for bleeding, perforation, and stricture in the EndoRotor arm will be no greater than that of the continued ablative therapy arm.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Activated Fibroblasts
Description
Percent reduction of activated fibroblasts in the area with Barrett's esophagus that was resected using EndoRotor at initial treatment session through the 12 month follow-up visit as per the histological findings of keyhole technique biopsies. - this point is only assessed in the first 5 EndoRotor subjects
Time Frame
12 months
Title
Percent Reduction of Barrett's Esophagus
Description
Percent reduction of Barrett's esophagus that was resected or ablated during the initial treatment session through the 12 month follow-up visit as calculated using the Prague classification measurements of estimated circumference and maximal length.
Time Frame
12 months
Title
Post Procedure Pain
Description
Assessment of subject post procedure pain as compared to the control arm by means of a visual analogue pain scale. The visual analogue pain scale used for this study allows a patient to record their pain using a scoring system from 0 to 10. Zero representing no pain, 5 representing moderate pain, and 10 representing the worst possible pain. Lower scores represent a better score.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who are greater than 30 and less than 90 years of age; inclusive of males and females. Subjects with confirmed Barrett's esophagus with dysplasia (low-grade or high-grade) and meeting at least one of the following criteria: Failed 3 ablative procedures (RFA and/or Cryotherapy). Failed at least 1 ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-procedure dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours. Residual Barrett's length is ≥1 cm and ≤6 cm. No confirmed evidence of esophageal adenocarcinoma (EAC) at the time of therapy. Subject capable of giving informed consent. Subject has a reasonable expectation for prolonged survival (greater than 2 years). Subject can tolerate repeated endoscopic procedures. Absence of strictures refractory to dilation that preclude the passage of the endoscope Patients who were on acid suppression therapy (i.e. PPIs) during the course of failed primary ablative therapy, and who can continue acid suppression therapy for the entire time they are on the clinical study. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 12 months, as indicated. Exclusion Criteria: Subject unable to give informed consent. Subject is unwilling to return for repeated endoscopies. Confirmed endoscopic and or histologic evidence of EAC at time of therapy. Residual Barrett's longer than 6 cm. Subjects with nodular Barrett's esophagus. Subjects who are on anticoagulant therapy that cannot be discontinued for 5 days before and after the procedure. Subjects with known coagulopathy defined as abnormal prothrombin or partial thromboplastin time. History of esophageal varices LA Grade B, C, or D esophagitis. Esophageal stricture refractory to dilation preventing passage of endoscope or catheter. Any previous esophageal surgery, except fundoplication without complications. Medically uncorrectable hypotension or hypertension. Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance). Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation. Subject has known severe psychiatric disorder, substance abuse, or other reason for being unable to follow trial follow-up instructions. Patient has a known significant concomitant illness with a life expectancy of less than 2 years. Subject is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis James, BA
Phone
508-847478
Email
alexis.james@interscopemed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffery B Ryan Jr, BA
Phone
617-360-1168
Email
jeffery.ryan@interscopemed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Wang, MD
Organizational Affiliation
The Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mayo Clinic
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
Bryan Linn
Phone
507-255-4631
Email
Linn.Bryan@mayo.edu
First Name & Middle Initial & Last Name & Degree
Kenneth Wang, MD
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krystle Bittner, BSN, RN
Phone
585-737-5242
Email
krystle_bittner@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Vivek Kaul, MD
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nima Mottacki, MS
Email
nima.mottacki@vgregion.se
First Name & Middle Initial & Last Name & Degree
Nima Mottacki, MD
Facility Name
NHS University College Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed HUSSEIN, MD
Phone
+44 7799 843218‬
Email
mohamed.hussein3@nhs.net
First Name & Middle Initial & Last Name & Degree
Christwishes Makahamadze
Phone
+447578254350
Email
christwishes.makahamadze@nhs.net
First Name & Middle Initial & Last Name & Degree
Rehan Haidry, MD
Facility Name
Nottingham University Hospitals NHS Trust and University of Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacobo Ortiz, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Endorotor Resection In Refractory Barrett's Dysplasia Patients

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