Actively Recruiting
Prospective Single Centre, Post Market, Randomized Controlled Trial to Demonstrate Feasibility, Safety and Efficacy of a 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
25 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
Researchers are evaluating a new device called the Pathfinder Endoscope Overtube to assist with colonic endoscopic submucosal dissection (ESD), a procedure to remove advanced colonic polyps. This trial aims to compare the feasibility, safety, and outcomes of ESD using this novel rigidizing overtube versus conventional ESD methods. The study particularly focuses on whether the overtube can improve procedure speed and reduce adverse events due to better scope stability and control. Participants will undergo endoscopic submucosal dissection either with the aid of the novel rigidizing overtube or through conventional means without the device. The overtube is soft and flexible during colonoscope introduction but becomes significantly stiffer when vacuum is applied, which may help straighten the colon and stabilize the scope tip during the procedure. The study is a prospective, randomized controlled trial with two groups assigned in a 1:1 ratio. During the procedure day, researchers will measure total procedure time, navigation time, dissection speed, closure time, and sedation time. They will also assess technical and clinical success, resection rates, and collect user feedback post-procedure. Participants will be monitored for safety and efficacy outcomes to determine if the novel overtube offers advantages over standard ESD techniques.
CONDITIONS
Brief 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 one of the following: lesions with prior resection or scar proximal to the sigmoid colon; granular lateral spreading tumors larger than 30mm; non granular lateral spreading tumors larger than 20mm; any suspected submucosal invasion or positive non lifting sign.
You will not qualify if you...
- Patient refused or 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (procedure day)
Participants undergo colonic endoscopic submucosal dissection either with the novel rigidizing overtube or through conventional means to remove eligible lesions.
1 procedure visit (in-person)
Duration - Duration not specified
Participants are monitored after the procedure to assess safety, clinical success, and effectiveness of the treatment.
Visits as per routine clinical care
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
S
Sara Al Yasin, BS
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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