Actively Recruiting
Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
Led by Baylor College of Medicine · Updated on 2026-03-24
66
Participants Needed
2
Research Sites
155 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
N
Neptune Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 22 years old or older
- Patients can provide written informed consent
- Patient is referred for ESD procedure of colonic neoplastic lesions with at least one of the following: A - Lesions with prior resection or scar at any size proximal to the sigmoid colon B - Granular lateral spreading tumors larger than 30 mm C - Non granular lateral spreading tumors larger than 20 mm D - Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign
You will not qualify if you...
- Patient refused or is unable to provide written informed consent
- Patient is pregnant or nursing
- Lesions with pedunculated morphology (Paris Ip, Ips)
- Lesions located within the sigmoid colon or rectum
- Lesions involving the appendiceal orifice or ileocecal valve
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
2
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Michael Mercado, BS
CONTACT
S
Sara Al Yasin, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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