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Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Recruiting
18-89 years
All
Phase N/A

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Overview

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.

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

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

NCT03626194

University of Colorado, Denver

28 May 2024

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