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Endoscopic Mucosal Resection and Cellular Matrix

Primary Purpose

Barretts Esophagus With High Grade Dysplasia, Barrett Adenocarcinoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acell MatriStem® Surgical Matrix
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Barretts Esophagus With High Grade Dysplasia focused on measuring Barrett's esophagus, Endoscopic Mucosal Resection

Eligibility Criteria

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

Inclusion Criteria

  • 18 and older
  • Male or female
  • Able to provide consent
  • Scheduled for standard of care endoscopy that may require initial EMR evaluation of esophageal lesions
  • Histological evidence of intestinal metaplasia with dysplasia or intramucosal carcinoma

Exclusion Criteria

  • Pregnant women
  • Age less than 18
  • Prior esophageal EMR or ESD in the same region
  • Anyone unable to provide informed consent
  • Medical co-morbidities precluding EGD evaluation
  • History of chemoradiotherapy to the neck/esophagus
  • Unable to stop anticoagulation therapy (non-steroid anti-inflammatory medications are permissible)

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Endoscopic submucosal resection with Extracelluar Matrix

Endoscopic submucosal resection standard of care

Arm Description

Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.

Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.

Outcomes

Primary Outcome Measures

Completeness of EMR Site Healing at Follow up Endoscopy
Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.

Secondary Outcome Measures

Presence of Stricture Formation at Follow up Endoscopy
Number of subjects to have symptomatic esophageal stricture formation requiring dilation, preventing dysphagia as determined by questionnaires, and mitigating formation of post-resection scarring as determined by blinded comparison of pre- and post-resection images (taken using white-light endoscopy and electron chromoendoscopy).

Full Information

First Posted
April 5, 2017
Last Updated
January 10, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03240679
Brief Title
Endoscopic Mucosal Resection and Cellular Matrix
Official Title
A Randomized Study of Biologic Scaffolds And Esophageal Healing Following Endoscopic Resection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty obtaining investigational product and study support.
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
June 20, 2017 (Actual)
Study Completion Date
June 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

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

5. Study Description

Brief Summary
This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barretts Esophagus With High Grade Dysplasia, Barrett Adenocarcinoma
Keywords
Barrett's esophagus, Endoscopic Mucosal Resection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot study 10 in each group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic submucosal resection with Extracelluar Matrix
Arm Type
Active Comparator
Arm Description
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
Arm Title
Endoscopic submucosal resection standard of care
Arm Type
No Intervention
Arm Description
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.
Intervention Type
Device
Intervention Name(s)
Acell MatriStem® Surgical Matrix
Intervention Description
Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.
Primary Outcome Measure Information:
Title
Completeness of EMR Site Healing at Follow up Endoscopy
Description
Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.
Time Frame
approximately 3-4 months post EMR
Secondary Outcome Measure Information:
Title
Presence of Stricture Formation at Follow up Endoscopy
Description
Number of subjects to have symptomatic esophageal stricture formation requiring dilation, preventing dysphagia as determined by questionnaires, and mitigating formation of post-resection scarring as determined by blinded comparison of pre- and post-resection images (taken using white-light endoscopy and electron chromoendoscopy).
Time Frame
approximately 3-4 months post EMR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Able to provide consent Scheduled for standard of care endoscopy that may require initial EMR evaluation of esophageal lesions Histological evidence of intestinal metaplasia with dysplasia or intramucosal carcinoma Exclusion Criteria Pregnant women Prior esophageal EMR or ESD in the same region Anyone unable to provide informed consent Medical co-morbidities precluding EGD evaluation History of chemoradiotherapy to the neck/esophagus Unable to stop anticoagulation therapy (non-steroid anti-inflammatory medications are permissible)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth K Wang
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Endoscopic Mucosal Resection and Cellular Matrix

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