Endoscopic Mucosal Resection and Cellular Matrix

Mayo Clinic

Status: Terminated

Conditions: Barretts Esophagus With High Grade Dysplasia; Barrett Adenocarcinoma

Treatments: Device: Acell MatriStem® Surgical Matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT03240679

16-006909

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Endoscopic submucosal resection with Extracelluar Matrix

Active Comparator group

Description:

Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.

Treatment:

Device: Acell MatriStem® Surgical Matrix

Endoscopic submucosal resection standard of care

No Intervention group

Description:

Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.