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GelPOINT® Path for Colorectal Polyp Removal

This study is looking at how well a device called GelPOINT® Path works when removing large or complex colon and rectal polyps (growths) using a procedure called endoscopic submucosal dissection (ESD). ESD is a way to remove polyps without major surgery. The GelPOINT® Path system helps doctors see better and work more easily during the procedure. We want to see if using GelPOINT® Path makes the ESD procedure faster and just as safe as standard ESD. This study is for adults aged 18 or older who need ESD for certain colorectal polyps. We plan to include about 30 people. The main goal is to see how quickly the procedure can be done.

Study design
This is an observational study, meaning doctors will watch and record information during your routine procedure. It will include about 30 adult participants at a single medical center.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, procedure speed, will be measured during the procedure itself. No further follow-up is specified.

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NCT07723937

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

Recruiting
Not specifiedAges 18+Observational
Baylor College of Medicine
~30 participants
Updated 2026-07-23 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Procedure Speed
Measured over During the index procedure

Conditions

Polyp Colorectal
Rectal Adenoma
Adenoma Colon Polyp

Explore related trials

Colorectal Polyp

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Tara Keihanian, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Tara Keihanian, MD
[email protected]
631-800-4142
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Procedure SpeedDuring the index procedure

    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.