What this study is
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 details
- Official title
- GelPOINT® Path-Assisted Endoscopic Submucosal Dissection for Colorectal Polyps: A Feasibility and Safety Study
- Sponsor
- Baylor College of Medicine
- Conditions
- Polyp Colorectal · Rectal Adenoma · Adenoma Colon Polyp
- Enrolling
- 30 people
- Starts
- 2026-05-19
- Est. completion
- 2027-04-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBaylor College of Medicine
Houston, Texas, United States
- Tara A Keihanian, MD · Contact631-800-4142Tara.Keihanian@bcm.edu
- Haydee Rochits Cueto · Contact713-798-3606Haydee.RochitsCueto@bcm.edu
- Mohamed Othman, MD · Sub-investigator
- Fares Ayoub, MD · Sub-investigator
Recruiting
Study team
Sponsor
Baylor College of Medicine
Study ID H-59028
Principal investigator
Tara Keihanian, MD
Baylor College of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.