Recruiting

Endoscopic Tissue Apposition

Sponsor:

University of Colorado, Denver

Code:

NCT03626194

Conditions

Endoscopic Tissue Apposition

Endoscopic Suturing

Endoscopic Clipping

Bariatric Endoscopy

Transoral Outlet Reduction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03626194

Start date

Dec 12, 2016

Status verified date

May, 2024

Completion date

Dec 16, 2026

Anticipated

Primary completion date

Dec 16, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Technical and clinical success in endoscopic tissue apposition [ Time Frame: From baseline to one year ]
  • Adverse Events [ Time Frame: From baseline to one year ]

Central Contacts and Locations

Central contacts

Abigail Lowe

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

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Abigail Lowe

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

Principal Investigator:

Mihir Wagh, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 21, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-05-21.