Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 20, 2021
CompletedStudy Start
First participant enrolled
August 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2023
CompletedFebruary 15, 2024
February 1, 2024
12 months
December 1, 2021
February 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cost of each closure
Total cost amount for equipment used in closure of GI defect
Day 1
Secondary Outcomes (2)
Rate of complete closure of GI defect
Day 1 (end of procedure)
Successful Tissue approximation
Day 1 (End of procedure)
Study Arms (2)
Through-the-Scope clip group
EXPERIMENTALThrough the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal.
X-Tack suturing group
ACTIVE COMPARATORUse of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient is \< 18 years of age.
- Patient refused and/or unable to provide consent.
- Patient is pregnant.
- Patient is currently incarcerated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (1)
Jawaid S, Khalaf M, Ayoub F, Zabad N, Fikry A, Daba G, Mercado M, Keihanian T, Othman M. RCT comparing the clinical efficacy and costs of two tissue approximation devices in the closure of large post-endoscopic resection defects. Surg Endosc. 2025 Aug;39(8):5442-5453. doi: 10.1007/s00464-025-11876-1. Epub 2025 Jul 10.
PMID: 40640617DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 1, 2021
First Posted
December 20, 2021
Study Start
August 23, 2022
Primary Completion
August 15, 2023
Study Completion
September 11, 2023
Last Updated
February 15, 2024
Record last verified: 2024-02