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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT06715332
Eligibility Criteria:
Inclusion criteria:
* Adult patient (age ≥18 and ≤80 years-old)
* Capability of understanding and complying with the study requirements, including signing the informed consent form.
* Patients with colorectal superficial mucosal neoplasia (clinically adenoma or early intramucosal cancer), scheduled to undergo endoscopic submucosal dissection (ESD).
Exclusion criteria:
* Patients unable or unwilling to provide consent.
* Patients with lesions unsuitable for ESD, including those suspicious of deep submucosal invasive cancer.
* Patients with lesions involving the appendiceal orifice or ileocaecal valve.
* Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake monitored anesthesia for the procedure.
* Poor performance status (Eastern Cooperation Oncology Group performance status ≥3).
* Pregnant women or those planning pregnancy or breastfeeding women.
* Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06715332
Study Brief:
Protocol Section:
NCT06715332