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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT07181759
Eligibility Criteria:
Inclusion Criteria:
* Patients with upper urinary tract stones and a cumulative stone diameter ≤3 cm;
* Patients scheduled to undergo "flexible ureteroscopic holmium laser lithotripsy";
* Age ≥18 years;
* Patients without psychiatric disorders or language dysfunction, capable of understanding the study and providing informed consent.
Exclusion Criteria:
* Patients requiring bilateral lithotripsy in a single-stage ureteroscopic procedure;
* Ipsilateral hydronephrosis with \>4 cm renal pelvic separation;
* Patients with a history of open or laparoscopic renal and/or ureteral surgery;
* Fever (body temperature ≥38°C) due to urinary tract infection or other causes within one week prior to surgery;
* Pregnant women;
* Patients with severe systemic diseases, cardiac diseases, pulmonary insufficiency, or vital organ failure unable to tolerate anesthesia or surgery (ASA score ≥3);
* Patients with anatomical abnormalities such as polycystic kidney, horseshoe kidney, or ectopic kidney;
* Patients with coagulation disorders (e.g., INR \>2.0 or platelet count \<80×10⁹/L);
* Patients currently participating in other device or drug clinical trials;
* Patients deemed ineligible for the trial by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07181759
Study Brief:
Protocol Section:
NCT07181759