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

Not Applicable

Completed

• Conditions: Gastrointestinal Neoplasms

• Registration Number: NCT05163665
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-20
• Study Start: 2022-08-23
• Primary Completion: 2023-08-15
• Study Completion: 2023-09-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Patient is greater than or equal to 18 years of age.
• Patient can provide informed consent.
• Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric, small bowel, or colorectal lesion.
• Post resection defect > 3cm.
• Lesion 2cm or greater from the dentate line.

Exclusion Criteria

• Patient is < 18 years of age.
• Patient refused and/or unable to provide consent.
• Patient is pregnant.
• Patient is currently incarcerated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cost of each closure	Day 1	Total cost amount for equipment used in closure of GI defect

Secondary Outcome Measures

Name	Time	Method
Rate of complete closure of GI defect	Day 1 (end of procedure)	Complete closure achieved by assigned closure type as assessed by performing physician
Successful Tissue approximation	Day 1 (End of procedure)	Less than or equal to 15mm of visible resection bed at its widest portion after the device is used for tissue approximation

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States