GelPOINT® Path-Assisted Endoscopic Removal of Colon and Rectal Polyps: A Feasibility and Safety Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBaylor College of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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).
Lesions with prior resection or scarring proximal to the sigmoid colon.
Disqualifiers
Younger than 18 years of age.
Unable or unwilling to provide informed consent.
Pregnant.
Pedunculated lesions (Paris classification Ip or Isp).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
30 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov