Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Launched by UNIVERSITY OF COLORADO, DENVER · Aug 7, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a technique called endoscopic tissue apposition, which involves using special tools to sew or clip tissues inside the gastrointestinal tract. The goal is to evaluate how effective and safe this procedure is for patients who need it for various reasons, such as closing holes or defects in the digestive system, or making adjustments after weight loss surgery. The researchers believe that this method can be both helpful and safe for patients undergoing these types of procedures.

To participate in this trial, you need to be at least 18 years old and scheduled for an endoscopy due to specific medical needs, like repairing tissue defects or complications from previous surgeries. Unfortunately, individuals who are pregnant, have certain bleeding disorders, or are experiencing severe health issues may not be eligible. If you choose to join the study, you’ll be monitored closely to ensure your safety and to gather important information about how well this technique works. Your participation could help improve future treatments for others in need of similar care.

Gender

ALL

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