Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones
Running, not enrolling · Not applicable
Conditions studied: Kidney Stones, Nephrolithiasis, Urolithiasis
In brief
This study tests moving kidney stones using focused ultrasound (referred to as ultrasonic propulsion). The study includes multiple population groups to investigate the ability of our technology to: a) move stone fragments to a location within the kidney to improve their chances of passage, and thus reduce the occurrence of additional symptomatic events and retreatment or b) move a symptomatic stone to relieve symptoms and pain.
Key facts
- Study ID
- NCT02028559
- Run by
- University of Washington
- People needed
- 172
- Starts
- 2013-12-17
- Expected to finish
- 2026-05-31
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Individuals suspected of having at least one kidney stone. This includes:
- Patients who are being managed with watchful waiting or medical therapy
- Patients who recently (but > 4 weeks) underwent lithotripsy treatment of their stones
- Patients scheduled for lithotripsy treatment
- Or
- Individuals suspected of having an obstructed stone. This includes:
- Patients presenting with renal colic
- Patients presenting with hydronephrosis or dilation of the ureter
- Primary Exclusion Criteria for all groups:
- Individuals under 18 years of age
- Individuals with non-echogenic stones
- Individuals unable or unwilling to comply with the follow-up requirements
- Individuals with a coagulation abnormality or taking blood thinners or other anticoagulant at clinically significant levels
- Individuals with mobility issues who are unable to comfortably lie 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 who have already received four previous ultrasonic propulsion procedures.
- Individuals who have received an ultrasonic propulsion treatment within the last 4 weeks.
- Additional Exclusion Criteria for Obstructing Stone population
- Individuals with a suspicion of kidney infection or exhibiting signs of sepsis
- Individuals whom the treating physician considers to be at high risk for serious alternate diagnoses such as acute infectious etiologies (e.g. cholecystitis, appendicitis), aortic aneurysm and rupture, or bowel disorders.
- Individuals who have undergone renal transplant, or individuals who will undergo dialysis.
- Individuals with bilateral hydronephrosis
- Individuals with a single kidney
- Individuals who have already received an ultrasonic propulsion investigative treatment for the same obstructing stone
Where it is running
- VA Puget Sound Health Care System — Seattle, Washington, United States
- University of Washington Department of Urology — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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