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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05163665
• Other study ID #: H-50701
• Status: Completed
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: September 11, 2023

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 11, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

Procedure:
• Closure type
Patients will have their endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) as per standard-of-care. Afterwards, patient will receive one of two intervention options for the closure of the GI defect following polyp removal.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost of each closure	Total cost amount for equipment used in closure of GI defect	Day 1
Secondary	Rate of complete closure of GI defect	Complete closure achieved by assigned closure type as assessed by performing physician	Day 1 (end of procedure)
Secondary	Successful Tissue approximation	Less than or equal to 15mm of visible resection bed at its widest portion after the device is used for tissue approximation	Day 1 (End of procedure)