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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT02683993
Eligibility Criteria:
Inclusion Criteria:
1. Subject will be older than 18 years of age
2. Subject was diagnosed with renal calculi meeting the following criteria:
* Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.
* Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.
3. Subject is a candidate for FURS procedure
4. Subject is willing and has signed the Informed Consent Form
Exclusion Criteria:
1. Subject has undergone a previous treatment for stones in the same kidney
2. Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
3. Female subject is pregnant
4. Concomitant anticoagulant medication that cannot be suspended during surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02683993
Study Brief:
Protocol Section:
NCT02683993