Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endoscopic Tissue Apposition
- Sponsor
- University of Colorado, Denver
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Technical and clinical success in endoscopic tissue apposition
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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)
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
Outcomes
Primary Outcomes
Technical and clinical success in endoscopic tissue apposition
Time Frame: From baseline to one year
Successful completion of endoscopic suturing/clipping and measured as clinical symptom improvement as well as objective evidence of resolution / improvement of underlying pathology / confirmed with radiologic contrast studies as needed..
Adverse Events
Time Frame: From baseline to one year
Based on ASGE criteria