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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT04285658
Eligibility Criteria:
Inclusion Criteria:
1. Males or females, 8-21 years of age, undergoing planned URS, SWL, or PCNL for the removal of at least one kidney and/or ureteral stone.
2. Parental/guardian or participant (if ≥ 18 years old) permission (informed consent), and if appropriate, child assent
2a. Individuals who are not able to provide consent/assent (whether ≥18 or \< 18 years) and/or not willing or able to complete questionnaires are eligible for participation for the stone clearance assessment and Electronic Health Record (EHR) surveillance if the legal guardian consents for study participation.
2b. Individuals for whom native-language questionnaires are not available can also participate in stone clearance assessment and EHR surveillance.
Exclusion Criteria:
1. Patients for whom conducting informed consent and baseline study procedures would confer additional risk (e.g. obstructing ureteral stone with fever requiring emergency surgery) and delay necessary immediate clinical care.
2. Parent/guardians or patients, who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
21 Years
Study:
NCT04285658
Study Brief:
Protocol Section:
NCT04285658