Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

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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.

Conditions:

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

🗓️ Study Start (Actual) 12 December 2016

🗓️ Primary Completion (Estimated) 16 December 2025

✅ Study Completion (Estimated) 16 December 2026

👥 Enrollment (Estimated) 500

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Aurora, Colorado, United States

📋 Eligibility Criteria

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

Ages Eligible for Study: 18 Years to 89 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 2 August 2018
First Submitted that Met QC Criteria 7 August 2018
First Posted 10 August 2018

Study Record Updates

Last Update Submitted that Met QC Criteria 20 May 2024
Last Update Posted 21 May 2024
Last Verified May 2024