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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT03195920
Eligibility Criteria:
Inclusion Criteria:
* Individuals presenting with one urinary stone-apparent on a computed tomography scan within the last 14 days
* Males and females aged 18 or older
* Capable of giving informed consent, and willing to have the informed consent process videotaped
* Stone size, as estimated by pre-operative computed tomography, with all dimensions 15 mm or less.
Exclusion Criteria:
* Individuals under 18 years of age
* Individuals with radiolucent stones
* Individuals with stones in the lower pole of kidney
* Individuals not following up in the treating hospital
* Individuals with history of cystinuria
* Individuals with urine pH below 5.5
* Individuals with untreated urinary tract infection
* Individuals who are not willing to use adequate method of contraception during the study period
* Women who are pregnant, lactating or planning pregnancy during the study period
* Individuals with a coagulation abnormality or taking prescription anticoagulants.
* Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side
* Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
* Individuals with a body mass index greater than 35
* Individuals with ASA score of 3 or greater general anesthesia risk level
* Known sensitivity to possible medications used before, during, or after the treatment procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03195920
Study Brief:
Protocol Section:
NCT03195920