Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
Recruiting now
Conditions studied: Endoscopic Tissue Apposition, Endoscopic Suturing, Endoscopic Clipping, Bariatric Endoscopy, Transoral Outlet Reduction, Endoscopic Sleeve Gastroplasty
In brief
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.
Key facts
- Study ID
- NCT03626194
- Run by
- University of Colorado, Denver
- People needed
- 500
- Starts
- 2016-12-12
- Expected to finish
- 2026-12-16
- Last updated by the study team
- 2024-05-21
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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