Using a new overtube to improve colonic endoscopic procedures
Prospective Single Centre, Post Market, Randomized Controlled Trial to Demonstrate Feasibility, Safety and Efficacy, of a Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
NA · Baylor College of Medicine · NCT06134687
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Baylor College of Medicine (other) |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT06134687 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who require ESD for specific types of colonic lesions.
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.
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 performed: While various overtube-assisted techniques have been explored, the specific use of the Pathfinder® Endoscope Overtube in this context is novel.
Eligibility criteria
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 this trial is running
Houston, Texas and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrointestinal Neoplasm, Endoscopic Submucosal Dissection