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

Recruiting now

Conditions studied: Polyp Colorectal, Rectal Adenoma, Adenoma Colon Polyp

In brief

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.

Key facts

Study ID

NCT07723937

Run by

Baylor College of Medicine

People needed

30

Starts

2026-05-19

Expected to finish

2027-04-30

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Baylor College of Medicine — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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