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Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

RecruitingObservational study

Who can join

Ages 18 to 89 · All sexes

Full eligibility criteria
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

About the study

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.

Sponsor: University of Colorado, Denver · Participants: 500 · Started: Dec 12, 2016

Contact the study team

Official record on ClinicalTrials.gov — NCT03626194

Locations in the U.S.

ColoradoUniversity of Colorado Hospital, Aurora

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.