Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

NCT03626194 | Recruiting

• 1 other identifier: 16-1826
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Central Study Contacts

Abigail Lowe

CONTACT

303-724-6070; ABIGAIL.LOWE@UCDENVER.EDU

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 10, 2018
• Study Start: December 12, 2016
• Primary Completion: December 16, 2025
• Study Completion (Estimated): December 16, 2026
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

US (1)