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RECRUITING
NCT06134687
NA

Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

Sponsor: Baylor College of Medicine

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Endoscopic Submucosal Dissection

Removal of study eligible lesions per endoscopic submucosal dissection

DEVICE

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