Status:
TERMINATED
Endoscopic Mucosal Resection and Cellular Matrix
Lead Sponsor:
Mayo Clinic
Conditions:
Barretts Esophagus With High Grade Dysplasia
Barrett Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2017
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03240679
Start Date
March 22 2017
End Date
June 20 2017
Last Update
February 6 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905