Intraoperative Assessment of of Burst Wave Lithotripsy (BWL) (NCT03873259) | Clinical Trial Compass
RecruitingNot Applicable
Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)
United States40 participantsStarted 2019-08-08
Plain-language summary
Burst Wave Lithotripsy (BWL) is a novel method of urinary stone fragmentation that uses multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. This is a single-arm feasibility study to test the ability of BWL to comminute (fragment) stones in humans.
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 presenting with at least one kidney stone apparent on CT
* Individuals scheduled for clinical stone removal via ureteroscopy (URS)
Exclusion Criteria:
* Individuals under 18 years of age
* Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.)
* Individuals with uncorrected bleeding disorders or coagulopathies
* Individuals taking a clinically significant anticoagulant dose at the time of the procedure
* Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm
* Individuals with a solitary kidney
* Individuals with a comorbidity risks which, at the discretion of the physician, would make the patient a poor candidate for the BWL procedure
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
Safety - Area of Tissue Injury
Timeframe: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
2
Effectiveness - Volume of Fragments < 2 mm
Timeframe: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.