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New treatment option for Renal Calculi
Official title Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
ClinicalTrials.gov ID: NCT03811171
What this study is testing
- What it's testing
- This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individuals presenting with at least one kidney stone apparent on CT.
- Stones must be within the upper urinary tract.
- Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
- Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).
You likely can't join if
- Acute untreated urinary tract infection or urosepsis.
- Uncorrected bleeding disorders or coagulopathies.
- Pregnancy.
- Uncorrected obstruction distal to the stone.
- Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
- Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
See the full eligibility criteria
- Individuals presenting with at least one kidney stone apparent on CT.
- Stones must be within the upper urinary tract.
- Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
- Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).
- Acute untreated urinary tract infection or urosepsis.
- Uncorrected bleeding disorders or coagulopathies.
- Pregnancy.
- Uncorrected obstruction distal to the stone.
- Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
- Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
- Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.).
- Patients unwilling to comply with the follow-up protocol, including post-procedure CT.
- Individuals under 18 years of age.
- Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse.
- Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.
- Solitary kidney
- Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment...
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- San Francisco, California, United States
- Seattle, Washington, United States
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; San Francisco, California, United States; Seattle, Washington, United States; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.