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Clinical Trials/NCT03240679
NCT03240679
Terminated
Not Applicable

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

Mayo Clinic1 site in 1 country3 target enrollmentMarch 22, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Barretts Esophagus With High Grade Dysplasia
Sponsor
Mayo Clinic
Enrollment
3
Locations
1
Primary Endpoint
Completeness of EMR Site Healing at Follow up Endoscopy
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 22, 2017
End Date
June 20, 2017
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kenneth K. Wang

Pricipal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Presence of Stricture Formation at Follow up Endoscopy(approximately 3-4 months post EMR)

Study Sites (1)

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