Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Recruiting

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

• Registration Number: NCT03626194
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-12
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2025-12-16
• Study Completion: 2026-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical and clinical success in endoscopic tissue apposition	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	From baseline to one year	Based on ASGE criteria

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States