Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
Purpose
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.
Conditions
- Endoscopic Tissue Apposition
- Endoscopic Suturing
- Endoscopic Clipping
- Bariatric Endoscopy
- Transoral Outlet Reduction
- Endoscopic Sleeve Gastroplasty
Eligibility
- Eligible Ages
- Between 18 Years and 89 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Other
- Time Perspective
- Prospective
Recruiting Locations
University of Colorado Hospital
Aurora, Colorado 80045
Aurora, Colorado 80045
More Details
- Status
- Recruiting
- Sponsor
- University of Colorado, Denver