Comparing traction and no traction in colonic endoscopic submucosal dissection
Official title: Comparison of the Efficacy of Using a Traction Device in Colonic Endoscopic Submucosal Dissection Versus Conventional ESD: A Randomized Clinical Trial
Run by Baylor College of Medicine · NCT06159634 · Data updated 2026-11-12
This study is testing if using a traction device during a specific type of colon surgery can help patients have quicker and easier procedures compared to standard methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Status | Recruiting |
| Started | December 5, 2023 |
| Main results expected | December 30, 2026 |
| Study ends | February 20, 2027 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT06159634 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are referred for ESD procedures for specific types of colonic neoplastic lesions.
✕Probably not a fit
Patients with pedunculated lesions or those who cannot provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of using a traction device during colonic endoscopic submucosal dissection (ESD) compared to conventional ESD techniques. Conducted at Baylor St. Luke's Medical Center, the study will involve a prospective, randomized, controlled design to assess clinical outcomes and procedural efficiency. The hypothesis is that traction will facilitate quicker dissections, particularly in challenging cases such as fibrotic lesions or those located in difficult anatomical positions. The trial will include patients with specific types of colonic neoplastic lesions who meet the eligibility criteria.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and faster procedures for patients undergoing ESD for complex colorectal polyps.
How similar studies have gone: While traction devices have shown promise in ESD in Eastern studies, data from Western populations is limited, making this approach somewhat novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient is ≥ 18 years old. 2. Patients can provide informed consent. 3. Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria: A- Lesions with prior resection or with scar at any size. B- Granular lateral spreading tumors (GLST) more than 3 cm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign. Exclusion Criteria: 1. Patient is \< 18 years old. 2. Patient refused and/or unable to provide consent. 3. Patient is a pregnant woman. 4. Lesions with morphology: pedunculated type (Paris IP, Ips). 5. Appendiceal orifice or IC valve lesions. 6. Patients with lesions removed with other techniques besides ESD (like hybrid ESD or submucosal tunneling technique STER and EMR).
Where it's running
-
Baylor College of Medicine
Houston, Texas, United States Recruiting -
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Mohamed Othman, MD — Baylor College of Medicine
- Study coordinator: Mai Khalaf, MD
- Email: Mai.Khalaf@bcm.edu
- Phone: 713-798-6696
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.