Endoscopic Mucosal Resection and Cellular Matrix

January 10, 2023 updated by: Kenneth K. Wang, Mayo Clinic

A Randomized Study of Biologic Scaffolds And Esophageal Healing Following Endoscopic Resection

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Endoscopic submucosal resection with Extracelluar Matrix
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
Device: Acell MatriStem® Surgical Matrix
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.
NO_INTERVENTION: Endoscopic submucosal resection standard of care
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of EMR Site Healing at Follow up Endoscopy
Time Frame: approximately 3-4 months post EMR
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.
approximately 3-4 months post EMR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Stricture Formation at Follow up Endoscopy
Time Frame: approximately 3-4 months post EMR
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).
approximately 3-4 months post EMR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 22, 2017

Primary Completion (ACTUAL)

June 20, 2017

Study Completion (ACTUAL)

June 20, 2017

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (ACTUAL)

August 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-006909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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