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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: GelPOINT® Path-Assisted ESD
Trial outcomes
Primary outcomes
1
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.
Time frame
During the index procedureSecondary outcomes
1
En Bloc Resection Rate
Percentage of lesions resected en bloc (in a single piece).
Time frame
During the index procedure2
Complete (R0) Resection Rate
Percentage of lesions with histologically negative lateral and vertical margins following resection.
Time frame
Pathology assessment following the index procedure (within approximately 2 weeks)Other outcomes
1
Intraprocedural Adverse Events
Incidence of intraprocedural adverse events, including muscularis propria injury, perforation, and bleeding.
Time frame
During the index procedure2
Post-Procedural Adverse Events
Incidence of delayed adverse events, including delayed bleeding, perforation, post-polypectomy syndrome, and other procedure-related complications.
Time frame
Up to 4 weeks afterSponsors and contacts
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Source ClinicalTrials.gov