Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Enrolling

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT03626194
16-1826

Details and patient eligibility

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Abigail Lowe

Data sourced from clinicaltrials.gov

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