Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Abigail Lowe; Phone Number: 303-724-6070; Email: ABIGAIL.LOWE@UCDENVER.EDU

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
      • Contact: Abigail Lowe; Phone Number: 303-724-6070; Email: ABIGAIL.LOWE@UCDENVER.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A prospective database/registry of patients undergoing endoscopic tissue apposition will be formed. Women and minorities will be included as they are frequently found to have indications for which endoscopic tissue apposition may be indicated.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adverse Events	Based on ASGE criteria	From baseline to one year

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Anticipated): December 16, 2025
• Study Completion (Anticipated): December 16, 2026

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 16-1826

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No