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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT04606758
Eligibility Criteria:
Inclusion Criteria:
* Patients planned for PCNL at participating institution
* Patients of all ethnic backgrounds
* Stone size over 10 mm in diameter and a density over 900 Hounsfield units
* Patients with a large calculus in the upper third of the ureter
Exclusion Criteria:
* Pregnancy
* infectious disease of the genitals;
* conditions that violate the configuration of the kidneys (curvature of the spinal column)
* anomalies in the development of the kidneys with impaired configuration and position of the kidneys (horseshoe kidney, bisque kidney, S-shaped kidney, L-shaped kidney, lumbar dystopia, iliac dystopia, pelvic dystopia)
* presence of nephrostomy drainage in the target kidney;
* urethral stricture or other reason leading to the inability to carry out ureteral catheterization;
* other conditions that are contraindications to surgical treatment, such as uncontrolled diabetes mellitus, acute cardiovascular conditions, liver failure, alcoholism, and drug addiction;
* patients who are unable to understand the purpose of the study or refuse further follow-up observation and instructions after treatment;
* patients with a history of mental illness;
* participation in another research that interferes with this research;
* acute renal failure;
* dissecting aortic aneurysm;
* acute hypertensive encephalopathy;
* heavy arterial bleeding;
* myocardial infarction less than six months before enrollment in the study;
* Stroke less than six months before enrollment in the study;
* Insufficiency of blood circulation III-IV New York Heart Association class;
* Severe rhythm and conduction disturbances;
* Increase in the level of liver transaminases by more than three times;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04606758
Study Brief:
Protocol Section:
NCT04606758