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NCT03626194Recruiting

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

University of Colorado, Denver

Start Date

12/12/2016

Completion Date

12/16/2026

Summary

This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition. 1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy. 1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.

Eligibility Criteria

Age Range: 18 years to 89 years

Inclusion Criteria: * Patients\>18 years of age undergoing endoscopy for any of the following indications: Indications for Tissue Apposition: * Closure of perforations * Closure of full thickness defects created during endoscopic full thickness resection * Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection * Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM) * Stent fixation * Closure of fistulas * Natural Orifice Transluminal Endoscopic Surgery defect closures * Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair) * Primary endoscopic sleeve gastroplasty Exclusion Criteria: * Patients unable or unwilling to provide consent * Pregnant patients * Coagulation disorders (INR \>1.8, platelet \<50,000) * GI Bleeding * Hemodynamic instability * Enrollment in another device or drug study that may confound the results

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Conditions

Endoscopic Tissue AppositionEndoscopic SuturingEndoscopic ClippingBariatric EndoscopyTransoral Outlet ReductionEndoscopic Sleeve Gastroplasty

Locations

University of Colorado Hospital

Aurora, Colorado 80045

United States