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OpenTrials
Completed

NCT Number: NCT05163665

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closure type

Procedure

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.

Primary outcomes

  1. Cost of each closure

    Time frame: Day 1

    Total cost amount for equipment used in closure of GI defect

Secondary outcomes

  1. Rate of complete closure of GI defect

    Time frame: Day 1 (end of procedure)

    Complete closure achieved by assigned closure type as assessed by performing physician

  2. Successful Tissue approximation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2021
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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