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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT05213702
Eligibility Criteria:
Inclusion Criteria:
* Subjects willing to sign informed consent form before initiation of any study specific procedures.
* Subjects diagnosed with kidney stones and planned for prone PCNL.
* Male/ non- pregnant female subjects between 18-75 years (both inclusive) of age at the time of informed consent.
* Subjects with renal stones of ≥1 cm or not managed by other stone treatments (e.g. shock wave lithotripsy, ureteroscopy).
* Serum creatinine of \< 1.2 mg/dl.
Exclusion Criteria:
* Subjects with bleeding disorders.
* Recent infection of the kidney or urinary tract which leads to pus accumulation in the kidney, i.e., Pyonephrosis.
* Subjects not able to have prone positions for surgical procedure due to comorbid conditions.
* Renal stones \< 1 cm and can managed by another technique.
* Patients with moderate to severe renal failure.
* Patients with congenital urinary tract anomalies.
* Patients on anticoagulation or antiplatelet therapy.
* Evidence or history of any other disease that in the opinion of the investigator would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
* Legal incapacity or other circumstances that render the subject unable to understand the nature, scope and possible consequences of the study.
* Clinically significant abnormal findings or condition (other than kidney stone), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05213702
Study Brief:
Protocol Section:
NCT05213702