Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT06317727
Eligibility Criteria:
Inclusion Criteria:
* \> 18 years of age.
* Ability to review the consent form prior to enrolment into the study • Patients must be mentally capable of understanding the information given • Patients must give written informed consent prior to undergoing any study-specific procedures.
* Patients must have at least one polyp (treatment naive, recurrent or residual) measuring \>5mm, located distal to the splenic flexure(i.e descending colon, Sigmoid colon, recto sigmoid junction and the rectum above the dentate line)
* Polyp(s) must be classified as Type 1 or Type 2, based on NICE (Narrow Band Imaging International Colorectal Endoscopic) classification; OR Type 1 or Type 2A based on JNET (Japan Narrow Band Imaging Expert Team) classification
* Patients must have a World Health Organization (WHO) performance status ≤ 2 . Patients must have a life expectancy of at least 6 months
Exclusion Criteria:
* \< 18 years of age.
* Patients who are incapacitated, unconscious or from a vulnerable population. • Patient who is pregnant or breastfeeding
* Patients unable to provide their own informed consent
* Patients with complex / challenging polyp(s), including but not limited to those that are: o \>20mm in size o Flat/bulky in shape o Extending beyond 2 haustra folds or occupying more than 1/3rd of the lumenal circumference o Located on the right colon proximal to the splenic flexure, ileocecal valve, hepatic and splenic flexure or dentate line of the rectum o Fibrosis from large lateral spreading lesions
* Patients with NICE Type 3 category polyps, OR JNET Type 2B or Type 3 polyps
* Patients with British Society of Gastroenterology (BSG) category C (high risk polyps).
* Five or more polyps in a single patient
* Grossly inflamed colonic mucosa with bleeding or ulcers
* Implanted colonic stents
* Polyposis syndromes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06317727
Study Brief:
Protocol Section:
NCT06317727