Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects

Gastrointestinal Neoplasms Clinical Trial

Official title: Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects

Status Completed

Clinical Trial Summary

This is a prospective, randomized research trial that aims to evaluate the clinical results of two different approximation methods to close the tissue defect caused by removing gastrointestinal polyps.

Clinical Trial Description

Closure of GI defects after endoscopic resection decreases the rate of post resection bleeding. Traditionally, standard TTS clips have been used to close GI wall defects with some success. However, complete apposition of the resection wall edges occurs only 68% of the time. Endoscopic suturing with the traditional Overstitch device can achieve complete closure in almost 100% of defects. However, this device is costly, requires the use of a double channel therapeutic endoscope, and at times can be difficult to maneuver. Recently, a novel FDA approved TTS tissue helix and suture device (X-tack) was developed to overcome the challenges of the traditional Overstitch device. Animal models have demonstrated the X-tack system is superior to TTS in effecting large mucosal defects and maintain similar durability. At BCM, we have been using the X-tack system routinely in closure of GI defects. ;

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms

• NCT number: NCT05163665
• Study type: Interventional
• Source: Baylor College of Medicine
• Status: Completed
• Phase: N/A
• Start date: August 23, 2022
• Completion date: September 11, 2023