GelPOINT Path-assisted endoscopic removal of colorectal polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational study evaluating the feasibility and safety of GelPOINT Path-assisted endoscopic submucosal dissection (ESD) for colorectal polyps. Adult patients undergoing ESD for eligible lesions will be enrolled and treated by experienced endoscopists as part of routine care. Outcomes will include technical feasibility, procedural performance, resection results, and any procedure-related adverse events, with follow-up around 4 weeks for delayed events. Data will be collected prospectively using standardized forms to assess whether the platform improves access, visualization, and stability during distal colon and rectal procedures without altering standard management. Approximately 30 patients are planned for enrollment at Baylor College of Medicine in Houston, TX.

Why it matters

Who can join: the full rules

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

Where it's running

• Baylor College of Medicine
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Tara Keihanian, MD — Baylor College of Medicine
• Study coordinator: Tara Keihanian, MD
• Email: Tara.Keihanian@bcm.edu
• Phone: 631-800-4142

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.