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Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
Sponsor: Baylor College of Medicine
Summary
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.
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
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2024-06-04
Completion Date
2027-05-30
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
Endoscopic Submucosal Dissection
Removal of study eligible lesions per endoscopic submucosal dissection
Novel Rigidizing Overtube
Utilization of the Novel Rigidizing Overtube (Pathfinder) to aid in performing colonic endoscopic submucosal dissection
Locations (2)
Baylor College of Medicine
Houston, Texas, United States
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, United States