Endoscopic Mucosal Resection and Cellular Matrix

Barrett Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03240679
• Other study ID #: 16-006909
• Status: Terminated
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: June 20, 2017

Study information

• Verified date: January 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 20, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Barrett Adenocarcinoma
• Barrett Esophagus
• Barretts Esophagus With High Grade Dysplasia

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials