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Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
Prospective Single Centre, Post Market, Randomized Controlled Trial to Demonstrate Feasibility, Safety and Efficacy, of a Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
Who can join
Ages 22 and older · All sexes
Full eligibility 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
About the study
The goal of this prospective, single centre, 1:1, Post Market, randomized controlled, Investigator Initiated trial, is to compare the feasibility, safety efficacy, and clinical outcomes of colonic endoscopic submucosal dissection (ESD) utilizing a novel rigidizing overtube called Pathfinder® Endoscope Overtube (Neptune Medical, Burlingame California, USA) device in comparison to conventional ESD.
The research team hypothesize that with utilizing a novel rigidizing overtube the procedure time including dissection speed and closure time will be faster due to higher scope stability and greater control over the scope tip. Subsequently, the investigators anticipate lower immediate or delayed adverse events.
What is being tested
- Endoscopic Submucosal Dissection (procedure)
- Novel Rigidizing Overtube (device)
Sponsor: Baylor College of Medicine · Participants: 66 · Started: Jun 4, 2024
Contact the study team
- Michael Mercado, BS · Phone: 713-798-3606
- Sara Al Yasin, BS · Phone: 713-798-2308
Official record on ClinicalTrials.gov — NCT06134687
Locations in the U.S.
| Texas | Baylor College of Medicine, Houston Baylor St. Lukes Medical Center (BSLMC), Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.