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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3
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.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
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.
Time frame: approximately 3-4 months post EMR
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).
Time frame: approximately 3-4 months post EMR
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