Endoscopic Mucosal Resection and Cellular Matrix

Not Applicable

Terminated

• Conditions: Barretts Esophagus With High Grade Dysplasia; Barrett Adenocarcinoma
• Interventions: Device: Acell MatriStem® Surgical Matrix

• Registration Number: NCT03240679
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-22
• Study First Submitted: 2017-04-05
• Primary Completion: 2017-06-20
• Study Completion: 2017-06-20
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Status Verified: 2023-01
• Results First Submitted: 2023-01-10
• Results First Submitted QC: 2023-01-10
• Last Update Submitted: 2023-01-10
• Results First Posted: 2023-02-06
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic submucosal resection with Extracelluar Matrix	Acell MatriStem® Surgical 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.

Primary Outcome Measures

Name	Time	Method
Completeness of EMR Site Healing at Follow up Endoscopy	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 Outcome Measures

Name	Time	Method
Presence of Stricture Formation at Follow up Endoscopy	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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States