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 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT04796792
Eligibility Criteria:
Inclusion Criteria:
* Individuals presenting with at least one kidney stone
* Stone with maximum dimension \> 2 mm and ≤ 7 mm as determined by clinical imaging
* Individuals with SCI - (Phase 2b only)
Exclusion Criteria:
* Individuals under 18 years of age
* Individuals who are pregnant or who are trying to get pregnant
* Prisoners
* with cognitive impairment that would limit their ability to comprehend their role in consent or participation.
* Individuals who are unable to read or understand English
* Individuals who are unable or unwilling to participate in follow up activities
* Individuals who cannot be positioned for ultrasound imaging
* Individuals with uncorrected bleeding disorders or coagulopathies
* Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure
* Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure
* Individuals with a solitary kidney
* Individuals with an uncorrected urinary tract obstruction
* Individuals with an untreated infection
* Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure
* Individuals who have received two previous investigational procedures for the same stone target
* Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04796792
Study Brief:
Protocol Section:
NCT04796792