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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT07159035
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged 18-75 years;
2. American Society of Anesthesiology (ASA) score 1-3;
3. Lower pole renal stones-single or multiple-with a maximal diameter of 1-2 cm confirmed by CT;
4. Ability to provide written informed consent and adhere to trial requirements.
Exclusion Criteria:
1. Significant urinary tract anatomical anomalies (e.g. horseshoe kidney, ileal conduit);
2. Stones located within a calyceal diverticulum;
3. History of open nephrolithotomy or ureterolithomy (due to resultant intrarenal anatomical distortion);
4. Absolute contraindications to either FANS-f-URS or mini-PCNL, including:
* Uncorrectable coagulopathy;
* Active, uncontrolled urinary tract infection;
* Severe cardiopulmonary disease precluding safe general anesthesia (e.g. decompensated heart failure, refractory COPD);
* Pregnancy;
* Inability to tolerate lithotomy or prone positioning;
5. Inability to understand or complete trial documentation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07159035
Study Brief:
Protocol Section:
NCT07159035