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

GelPOINT® Path-Assisted Endoscopic Submucosal Dissection for Colorectal Polyps: A Feasibility and Safety Study

Who can join

Ages 18 and older · All sexes

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

About the study

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 events.

Sponsor: Baylor College of Medicine · Participants: 30 · Started: May 19, 2026

Contact the study team

• Tara Keihanian, MD · Phone: 631-800-4142

Official record on ClinicalTrials.gov — NCT07723937

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.