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Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

RecruitingNAAges 22 Years - anyAllBaylor College of Medicine
NCT06134687 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Endoscopic Submucosal Dissection
  • Novel Rigidizing Overtube
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Where

2 sites
Baylor College of Medicine
Houston, United States
Baylor St. Lukes Medical Center (BSLMC)
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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