Recruiting

GelPOINT® Path

Sponsor:

Baylor College of Medicine

Code:

NCT07723937

Conditions

Polyp Colorectal

Rectal Adenoma

Adenoma Colon Polyp

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07723937

Start date

May 19, 2026

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Mar 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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 and Locations

Central contacts

Tara Keihanian, MD

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

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Tara A Keihanian, MD

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

Haydee Rochits Cueto

713-798-3606Haydee.RochitsCueto@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jul 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-07-23.