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

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.

Study Overview

• Status: Recruiting
• Conditions: Polyp Colorectal; Rectal Adenoma; Adenoma Colon Polyp

Detailed Description

Endoscopic submucosal dissection (ESD) is an advanced endoscopic technique that enables en bloc removal of large or complex colorectal lesions while preserving the bowel and reducing the need for surgical resection. Despite its advantages, colorectal ESD remains technically demanding because of limited visualization, unstable luminal distension, and restricted instrument maneuverability, particularly in the distal colon and rectum.

The GelPOINT® Path transanal access platform has been widely used in transanal minimally invasive surgery (TAMIS) to provide stable insufflation and improved access for rectal procedures. This study will evaluate whether incorporating the GelPOINT® Path platform into colorectal ESD can improve procedural efficiency while maintaining the safety and effectiveness of standard ESD.

This is a prospective, single-center, observational feasibility and safety study enrolling approximately 30 adult patients undergoing ESD for eligible colorectal lesions. All procedures will be performed by experienced advanced endoscopists as part of routine clinical care. The use of the GelPOINT® Path platform will be determined by the treating physician according to standard clinical practice. No experimental therapeutic interventions or deviations from routine clinical management will occur.

Clinical, procedural, pathological, and follow-up data will be collected prospectively using standardized case report forms. Outcomes will include technical success, procedure time, dissection speed, en bloc resection, R0 resection, curative resection, device performance, operator workload, and intraprocedural and delayed adverse events. Participants will be followed for approximately 4 weeks after the procedure to evaluate post-procedural safety.

The findings from this study are expected to provide important feasibility and safety data regarding the use of the GelPOINT® Path platform as an adjunct to colorectal ESD and may help guide the design of future comparative studies evaluating its clinical effectiveness.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Tara Keihanian, MD; Phone Number: 631-800-4142; Email: Tara.Keihanian@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Sub-Investigator: Mohamed Othman, MD
      • Sub-Investigator: Fares Ayoub, MD
      • Contact: Haydee Rochits Cueto; Phone Number: 713-798-3606; Email: Haydee.RochitsCueto@bcm.edu
      • Contact: Tara A Keihanian, MD; Phone Number: 631-800-4142; Email: Tara.Keihanian@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
En Bloc Resection Rate	Percentage of lesions resected en bloc (in a single piece).	During the index procedure
Complete (R0) Resection Rate	Percentage of lesions with histologically negative lateral and vertical margins following resection.	Pathology assessment following the index procedure (within approximately 2 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraprocedural Adverse Events	Incidence of intraprocedural adverse events, including muscularis propria injury, perforation, and bleeding.	During the index procedure
Post-Procedural Adverse Events	Incidence of delayed adverse events, including delayed bleeding, perforation, post-polypectomy syndrome, and other procedure-related complications.	Up to 4 weeks after

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Tara Keihanian, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2026
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: H-59028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No