Evaluating the safety and effectiveness of endoscopic tissue apposition techniques
Official title: Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
Run by University of Colorado, Denver · NCT03626194 · Data updated 2026-11-12
This study is testing if new endoscopic techniques for stitching or clipping tissue during gastrointestinal procedures are safe and effective for patients with certain digestive conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | December 12, 2016 |
| Main results expected | December 16, 2025 |
| Study ends | December 16, 2026 |
| Registry record updated | May 21, 2024 |
| Trial ID | NCT03626194 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years undergoing endoscopy for conditions such as perforations, fistulas, or post-bariatric surgery complications.
✕Probably not a fit
Patients who are pregnant, have coagulation disorders, or are experiencing GI bleeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the efficacy and safety of endoscopic tissue apposition techniques, including suturing and clipping, in patients undergoing gastrointestinal endoscopy. It involves a prospective registry of patients who meet specific inclusion criteria related to various gastrointestinal conditions requiring tissue apposition. The study will collect data on patient outcomes to evaluate the effectiveness of these endoscopic procedures in clinical practice.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of endoscopic procedures, leading to better patient outcomes in gastrointestinal surgeries.
How similar studies have gone: While this approach is being evaluated in this study, similar endoscopic techniques have shown promise in other studies, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Colorado Hospital
Aurora, Colorado, United States Recruiting
Study contacts
- Study coordinator: Abigail Lowe
- Email: ABIGAIL.LOWE@UCDENVER.EDU
- Phone: 303-724-6070
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Endoscopic Sleeve Gastroplasty for treating obesity
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-
Endoscopic sleeve gastroplasty for obese kidney transplant candidates
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.