Endoscopic Mucosal Resection and Cellular Matrix

Study Overview
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Brief Summary
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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.

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

Conditions
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Barretts Esophagus With High Grade Dysplasia, Barrett Adenocarcinoma

Intervention / Treatment
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* Device: Acell MatriStem® Surgical Matrix


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study 10 in each group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic submucosal resection with Extracelluar Matrix<br>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<br>* 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.<br>|
| No Intervention: Endoscopic submucosal resection standard of care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | approximately 3-4 months post EMR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | approximately 3-4 months post EMR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's esophagus, Endoscopic Mucosal Resection