Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Endoscopic Sleeve Gastroplasty Clinical Trial

Official title:

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03626194
• Other study ID #: 16-1826
• Status: Recruiting
• Start date: December 12, 2016
• Est. completion date: December 16, 2026

Study information

• Verified date: April 2023
• Source: University of Colorado, Denver
• Contact: Abigail Lowe
• Phone: 303-724-6070
• Email: ABIGAIL.LOWE[@]UCDENVER.EDU
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 16, 2026
• Est. primary completion date: December 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical and clinical success in endoscopic tissue apposition	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..	From baseline to one year
Primary	Adverse Events	Based on ASGE criteria	From baseline to one year