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

NCT07723937 | Recruiting

• 1 other identifier: H-59028
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polyp Colorectal; Rectal Adenoma; Adenoma Colon Polyp

Outcome Measures

Primary Outcomes (1)

• Procedure Speed

  Procedure speed, calculated as lesion surface area (cm²) divided by total procedure time (hours), to evaluate the technical performance of GelPOINT® Path-assisted endoscopic submucosal dissection.

  During the index procedure

Secondary Outcomes (2)

• En Bloc Resection Rate

  During the index procedure

• Complete (R0) Resection Rate

  Pathology assessment following the index procedure (within approximately 2 weeks)

Other Outcomes (2)

• Intraprocedural Adverse Events

  During the index procedure

• Post-Procedural Adverse Events

  Up to 4 weeks after

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients referred for endoscopic submucosal dissection (ESD) of eligible colorectal neoplastic lesions located in the transverse colon, descending colon, rectosigmoid colon, or rectum who meet all study eligibility criteria and provide written informed consent.

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Tara Keihanian, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Keihanian, MD

CONTACT

631-800-4142; Tara.Keihanian@bcm.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-04

Locations

US (1)