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

Conditions

• Adenoma Colon Polyp
• Polyp Colorectal
• Rectal Adenoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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 Dates

First listed

Jul 23, 2026

Start date

May 19, 2026

Status verified

Apr 2026

Primary completion

Mar 25, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: GelPOINT® Path-Assisted ESD
  Adult participants undergoing endoscopic submucosal dissection (ESD) for eligible colorectal polyps using the GelPOINT® Path transanal access platform as part of standard clinical care. The study will prospectively evaluate the feasibility, technical performance, and safety of GelPOINT® Path-assisted ESD, including procedural outcomes and procedure-related adverse events.

Primary Outcome Measure

Procedure Speed [ Time Frame: During the index procedure ]

Central Contacts

• Tara Keihanian, MD
  631-800-4142
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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