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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT03105206
Eligibility Criteria:
Inclusion Criteria:
* • Subject has provided informed consent and indicated a willingness to comply with study treatments
* Subject is 18-70 yrs of age
* Subject can be either male or female
* Subject has a diagnosis of low pole renal stones according to CT urography(CTU) or intravenous pyelogram (IVP) results
* Subject has a single stone 1\~2cm in size (KUB), or multiple stones 1\~2cm in cumulative size (KUB), and is a surgical candidate for the ureteroscopic approach
Exclusion Criteria:
* • Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
* Subject has been diagnosed with a urethral stricture or bladder neck contracture
* Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
* Subject has severe hematuria that might blur the vision of the endoscopy
* Subject is pregnant or in monthly period
* Subject has coexistent disease like systemic disease, heart disease, lung disfunction or other diseases that could not tolerate the endoscopic surgery or anesthesia.
* Subject has unadjusted diabetes or high blood pressure
* Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
* Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (2 weeks)
* Subject has been diagnosed with hydronephrosis larger than 3cm according to the B-scan ultrasonography examination
* Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03105206
Study Brief:
Protocol Section:
NCT03105206