Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones (NCT02028559) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones
United States172 participantsStarted 2013-12-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of Stone Motion Caused by Ultrasound
Timeframe: At the time of the procedure. To be evaluated with each therapy pulse over an approximately 1-hour study. Confirmed with post-procedure review of the study video.
2
Measurement of Stone Passage
Timeframe: Measurement occurs over 3 weeks (weekly phone call or email encounter with the subject) plus review of the subject's medical chart up to the point the subject is exited from the study.
3
Measurement of Relapse
Timeframe: Measurement up to 5 years post-procedure. This includes a phone call or email exchange semi-annually for up to 3-years and a medical record review (including imaging) semi-annually for up to 5-years.