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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT05029934
Eligibility Criteria:
Inclusion Criteria:
* Patients with a ≥20mm colon non-pedunculated polyp who are undergoing an ESD or EMR resection
* signed Informed Consent
Exclusion Criteria:
* Patients with known (biopsy proven) or strongly suspected invasive carcinoma in a potential study polyp
* Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
* ulcerated depressed lesions (as defined by Paris Classification type III)
* polyposis syndromes
* inflammatory bowel disease
* emergency colonoscopy
* Poor general health (ASA (American Society of Anaesthesiologists) class\>3)
* Patients with coagulopathy with an elevated International Normalized Ratio (INR )≥1.5, or platelets \<50
* Poor bowel preparation
* pregnancy or breastfeeding
* Intervention planned using ORISE™ (Boston Medical) or LIFTUP™ (Ovesco) as lifting agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT05029934
Study Brief:
Protocol Section:
NCT05029934