Status:
RECRUITING
Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Neptune Medical, Inc.
Conditions:
Gastrointestinal Neoplasm
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 end...
Detailed Description
Endoscopic submucosal dissection (ESD) is preferred resection method for advanced colonic polyp due to its higher rates of en bloc and R0 resection which lead to higher curative resection rate.1 In co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06134687
Start Date
June 4 2024
End Date
October 30 2025
Last Update
August 18 2025
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, United States, 77030