Ultrasound to Facilitate Stone Passage
Recruiting now · Not applicable
Conditions studied: Urinary Stone, Urinary Calculi
In brief
This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.
Key facts
- Study ID
- NCT04796792
- Run by
- University of Washington
- People needed
- 140
- Starts
- 2023-04-01
- Expected to finish
- 2028-10-31
- Last updated by the study team
- 2025-12-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- VA Puget Sound Health Care System — Seattle, Washington, United States (enrolling)
- University of Washington — Seattle, Washington, United States (enrolling)
- Indiana University Health - North Hospital — Carmel, Indiana, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.