Actively Recruiting

Age: 18Years - 89Years
All Genders
NCT03626194

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Led by University of Colorado, Denver · Updated on 2024-05-21

500

Participants Needed

1

Research Sites

522 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age undergoing endoscopy for specific indications
  • Indications include closure of perforations, full thickness defects from endoscopic resection, defects after endoscopic submucosal dissection and 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
Not Eligible

You will not qualify if you...

  • Patients unable or unwilling to provide consent
  • Pregnant patients
  • Coagulation disorders (INR greater than 1.8, platelet count less than 50,000)
  • Gastrointestinal bleeding
  • Hemodynamic instability
  • Enrollment in another device or drug study that may affect results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

A

Abigail Lowe

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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