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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT07159503
Eligibility Criteria:
Inclusion Criteria:
* Patients with upper urinary tract calculi, where the maximum diameter of a single calculus or the cumulative diameter of multiple calculi is 2-4 cm
* Age between 18 and 80 years, regardless of gender
* Mentally sound and able to comprehend study details and provide informed consent
Exclusion Criteria:
* Presence of ureteral stricture or history thereof
* Previous open or laparoscopic renal and/or ureteral surgery
* Fever (body temperature ≥ 38℃) due to urinary tract infection or other causes within one week prior to surgery
* Pregnancy, lactation, or menstruation at the time of surgery
* ASA classification \> Grade 3, indicating severe systemic disease that contraindicates anesthesia or surgery
* Renal anatomical anomalies such as polycystic kidney, horseshoe kidney, or ectopic kidney
* Coagulation dysfunction (e.g., INR \> 1.5 or platelet count \< 80 × 10⁹/L)
* Intraoperative failure to successfully place the ureteral access sheath
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07159503
Study Brief:
Protocol Section:
NCT07159503