Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Bariatric Endoscopy; Endoscopic Clipping; Transoral Outlet Reduction; Endoscopic Suturing; Endoscopic Sleeve Gastroplasty; Endoscopic Tissue Apposition

Study type: Observational

Funder types: Other

Identifiers

NCT03626194

16-1826

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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