NCT03811171 Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
| NCT ID | NCT03811171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SonoMotion |
| Condition | Renal Calculi |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2019-08-20 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2019-08-20 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else. Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.
Eligibility Criteria
Inclusion 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). Exclusion Criteria: * 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 passage.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03811171 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Calculi. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03811171 currently recruiting?
Yes, NCT03811171 is actively recruiting participants. Contact the research team at oren.levy@sonomotion.com for enrollment information.
Where is the NCT03811171 trial being conducted?
This trial is being conducted at San Diego, United States, San Francisco, United States, Seattle, United States, Edmonton, Canada and 2 additional locations.
Who is sponsoring the NCT03811171 clinical trial?
NCT03811171 is sponsored by SonoMotion. The trial plans to enroll 70 participants.