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

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

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.

Acell MatriStem® Surgical Matrix

Kenneth K Wang

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.

Endoscopic Mucosal Resection and Cellular Matrix

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

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.

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).

Mayo Clinic

Pricipal Investigator

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

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.

Endoscopic Submucosal Resection With Extracelluar Matrix

Endoscopic Submucosal Resection Standard of Care

Total

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Study terminated due to difficulty of obtaining investigational product and study support. Only 3 subjects accrued into the study who underwent initial endoscopy with treatment and follow-up endoscopies approximately 3 months later.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Endoscopic Mucosal Resection and Cellular Matrix	NCT03240679	Barretts Esopha... Barrett Adenoca...	Acell MatriStem...	18 Years -	Mayo Clinic
Endoscopic Mucosal Resection and Cellular Matrix	NCT03240679	Barretts Esopha... Barrett Adenoca...	Acell MatriStem...	18 Years -	Mayo Clinic

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