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
Conditions
Endoscopic Tissue AppositionEndoscopic SuturingEndoscopic ClippingBariatric EndoscopyTransoral Outlet ReductionEndoscopic Sleeve Gastroplasty
Locations
University of Colorado Hospital
Aurora, Colorado 80045
United States