Using a new overtube to improve colonic endoscopic procedures
Official title: Prospective Single Centre, Post Market, Randomized Controlled Trial to Demonstrate Feasibility, Safety and Efficacy, of a Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
Run by Baylor College of Medicine · NCT06134687 · Data updated 2026-11-12
This study is testing a new tool to see if it can make colon procedures easier and safer for patients with certain growths in their intestines.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Status | Recruiting |
| Started | June 4, 2024 |
| Main results expected | December 4, 2026 |
| Study ends | May 30, 2027 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT06134687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 22 and older who require ESD for specific types of colonic lesions.
✕Probably not a fit
Patients with lesions located in the sigmoid colon or rectum, or those with certain lesion morphologies, may 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 feasibility, safety, and clinical outcomes of using a novel rigidizing overtube, the Pathfinder® Endoscope Overtube, during colonic endoscopic submucosal dissection (ESD) compared to conventional methods. The study is a prospective, single-center, randomized controlled trial that hypothesizes that the new overtube will enhance scope stability, leading to faster procedure times and reduced adverse events. Participants will be patients referred for ESD of colonic neoplastic lesions, and the trial will assess various metrics related to the procedure's success and safety.
Why it matters
Potential benefit: If successful, this approach could lead to faster and safer endoscopic procedures for patients with colonic neoplasms.
How similar studies have gone: While various overtube-assisted techniques have been explored, the specific use of the Pathfinder® Endoscope Overtube in this context is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is ≥ 22 years old. * Patients can provide written informed consent. * 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 proximal to the sigmoid colon. B - Granular lateral spreading tumors (GLST) more than 30mm. 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: * Patient refused and/or unable to provide written informed consent. * Patient is a pregnant or nursing woman. * Lesions with morphology: pedunculated type (Paris Ip, Ips). * Lesions located within the sigmoid colon or rectum. * Lesions involving appendiceal orifice or ileocecal valve
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: Michael Mercado, BS
- Email: Michael.Mercado@bcm.edu
- Phone: 713-798-3606
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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.