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

Primary Purpose

Gastrointestinal Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Closure type
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms focused on measuring Closure of GI defects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Through-the-Scope clip group

X-Tack suturing group

Arm Description

Through the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal.

Use of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal.

Outcomes

Primary Outcome Measures

Cost of each closure
Total cost amount for equipment used in closure of GI defect

Secondary Outcome Measures

Rate of complete closure of GI defect
Complete closure achieved by assigned closure type as assessed by performing physician
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

Full Information

First Posted
December 1, 2021
Last Updated
September 12, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05163665
Brief Title
Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
Official Title
Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms
Keywords
Closure of GI defects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Through-the-Scope clip group
Arm Type
Experimental
Arm Description
Through the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal.
Arm Title
X-Tack suturing group
Arm Type
Active Comparator
Arm Description
Use of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal.
Intervention Type
Procedure
Intervention Name(s)
Closure type
Intervention Description
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 Outcome Measure Information:
Title
Cost of each closure
Description
Total cost amount for equipment used in closure of GI defect
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Rate of complete closure of GI defect
Description
Complete closure achieved by assigned closure type as assessed by performing physician
Time Frame
Day 1 (end of procedure)
Title
Successful Tissue approximation
Description
Less than or equal to 15mm of visible resection bed at its widest portion after the device is used for tissue approximation
Time Frame
Day 1 (End of procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Mercado
Phone
713-798-3606
Email
Michael.Mercado@bcm.edu
First Name & Middle Initial & Last Name & Degree
Noor Zabad, MPH
Phone
7137982308
Email
Noor.Zabad@bcm.edu
First Name & Middle Initial & Last Name & Degree
Salmaan Jawaid, MD
First Name & Middle Initial & Last Name & Degree
Mohamed Othman, MD

12. IPD Sharing Statement

Learn more about this trial

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

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