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:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT05517369
Eligibility Criteria:
Inclusion Criteria:
* Non-pedunculated lesion in the colorectum (epithelial lesion, 2-3 cm).
* Ablation medically indicated and possible (coagulation, etc. - as determined by the center)
Exclusion Criteria:
* Age \< 18 years
* Pedunculated lesion (Paris0-Ip)
* Size of the lesion \<2cm or \>3cm
* Pregnant and breastfeeding women
* Patient not capable of informed consent / consent not possible
* Bioptic evidence of a carcinoma / high probability of the presence of a carcinoma
* Non-lifting sign / known recurrence after previous therapy
* Impassable stenosis in the colon / rectum
* Patients with compelling need for therapeutic anticoagulation or dual antiplatelet therapy that cannot be discontinued for resection
* As per contraindications from the AWC \& LiftUp Instructions for Use:
* The AWC is not to be used if flexible-endoscopic procedures are contraindicated.
* The LiftUp gel should not be used when flexible endoscopic procedures are contraindicated, especially in combination with submucosal endoscopic resection (EMR) or endoscopic submucosal dissection (ESD) injectables.
* LiftUp gel should not be used in patients with known sensitivity to any of the ingredients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05517369
Study Brief:
Protocol Section:
NCT05517369