Traction vs. No Traction in Colonic ESD
Part of paid clinical trials in Houston, Texas.
- Sponsor
- Baylor College of Medicine
- Study ID
- NCT06159634
- Status
- Recruiting
Conditions
- Gastrointestinal Neoplasm
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Endoscopic Submucosal Dissection — PROCEDUREEndoscopic submucosal dissection (ESD) will be the technique used to remove target lesions.
- Traction Device — DEVICEUse of traction device to aid in removing target lesions
Study Details
The goal of this prospective, randomized, controlled trial conducted at Baylor St. Luke's Medical Center is to compare the effectiveness and clinical outcomes of using a traction device in colonic endoscopic submucosal dissection (ESD) to those of using conventional ESD. The investigators of this study hypothesize that use of the traction device will help expedite colonic endoscopic submucosal dissections.
Key Dates
- Start date
- Dec 5, 2023
- Status verified
- Feb 2026
- Primary completion
- Dec 30, 2026
- Completion
- Feb 20, 2027
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: ESD with traction deviceESD of target lesion will be performed with the assistance of a traction device.
- Active Comparator: Control armESD of target lesion will be performed without the use of a traction device
Primary Outcome Measure
Dissection speed [ Time Frame: Day 1 (procedure day) ]
Central Contacts
- Mai Khalaf, MD713-798-6696
- Michael Mercado, BS713-798-3606
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | |
| Baylor St. Lukes Medical Center (BSLMC) | Houston | Texas | 77030 |
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