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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03240679
Other study ID # 16-006909
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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