Evaluating the safety and effectiveness of endoscopic tissue apposition techniques
Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03626194 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years undergoing endoscopy for conditions such as perforations, fistulas, or post-bariatric surgery complications.
Not a fit: Patients who are pregnant, have coagulation disorders, or are experiencing GI bleeding may not benefit from this study.
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 performed: While this approach is being evaluated in this study, similar endoscopic techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
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 this trial is running
Aurora, Colorado
- University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Abigail Lowe
- Email: ABIGAIL.LOWE@UCDENVER.EDU
- Phone: 303-724-6070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.