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GelPOINT® Path-Assisted Endoscopic Removal of Colon and Rectal Polyps: A Feasibility and Safety Study

Recruitingn/aAges 18 Years - anyAllBaylor College of Medicine
NCT07723937 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective, single-center, observational feasibility and safety study will evaluate the use of the GelPOINT® Path transanal access platform during endoscopic submucosal dissection (ESD) for the removal of colorectal polyps. The GelPOINT® Path system is designed to improve access, maintain stable insufflation, and enhance visualization during advanced endoscopic procedures. The study will enroll adult patients undergoing ESD for eligible colorectal lesions. The primary objective is to evaluate the technical feasibility, procedural performance, and safety of GelPOINT® Path-assisted ESD. Procedural outcomes, including procedure speed, technical success, resection outcomes, and procedure-related adverse events, will be collected prospectively. Participants will receive standard clinical care and will be followed for approximately 4 weeks after the procedure to assess delayed adverse e

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 years or older. * Able and willing to provide written informed consent. * Colorectal polyps located in the transverse colon, descending colon, rectosigmoid colon, or rectum (rectal lesions located at least 2 cm from the anal verge). * Referred for endoscopic submucosal dissection (ESD) of colorectal neoplastic lesions meeting at least one of the following criteria: * Lesions with prior resection or scarring proximal to the sigmoid colon. * Granular lateral spreading tumors (GLST) \>30 mm. * Non-granular lateral spreading tumors (NGLST) \>20 mm. * Lesions with suspected submucosal invasion, including Paris classification IIa+IIc lesions or lesions with a positive non-lifting sign Exclusion Criteria: * Younger than 18 years of age. * Unable or unwilling to provide informed consent. * Pregnant. * Pedunculated lesions (Paris classification Ip or Isp). * Lesions involving the appendix or ileocecal valve
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What it tests

  • Not listed
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Where

1 site
Baylor College of Medicine
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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