Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03811171|
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : May 19, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Calculi Urinary Calculi||Device: Break Wave extracorporeal lithotripsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones|
|Actual Study Start Date :||August 20, 2019|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||June 30, 2023|
The arm receives the investigational Break Wave procedure.
Device: Break Wave extracorporeal lithotripsy
The Break Wave device will be used to exert a low amplitude burst of ultrasound waves focused at the kidney stone. The primary components of the device include an 85 mm aperture diameter therapy probe driven by a high voltage generator. The therapy probe has a cavity in the middle to accommodate coaxial alignment of an ultrasound imaging probe for treatment guidance.
- Primary Effectiveness Outcome - Stone Fragmentation [ Time Frame: 12 weeks post-treatment ]Stone fragmentation as determined by stone passage or imaging confirmation.
- Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia [ Time Frame: 12 weeks post-treatment ]The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.
- Secondary effectiveness outcome - Stone Free Status [ Time Frame: 12 weeks post-treatment ]Radiographic evidence (CT imaging) of stone free status.
- Secondary effectiveness outcome - Residual fragment size [ Time Frame: 12 weeks post-treatment ]Presence of only stone fragments small enough to pass (less than or equal to 4 mm).
- Secondary safety outcome - Adverse events [ Time Frame: 12 weeks post-treatment ]documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events associated with shock wave lithotripsy (SWL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811171
|Contact: Oren Levy, PhDemail@example.com|
|United States, California|
|University of California San Diego Health||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Roger Sur|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Thomas Chi, MD 415-353-2200 firstname.lastname@example.org|
|Contact: Ralph Wang, MD 415-353-1634 email@example.com|
|United States, Washington|
|University of Washington Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Barb Burke|
|University of Alberta, Division of Urology||Recruiting|
|Edmonton, Alberta, Canada, T6G1Z1|
|Contact: Shuba De, MD 780-407-5800 firstname.lastname@example.org|
|Contact: Breanne Stewart, RN 780-974-8606 email@example.com|
|Canada, British Columbia|
|Vancouver General Hospital Stone Centre||Recruiting|
|Vancouver, British Columbia, Canada, BC V5Z 1M9|
|Contact: Ben Chew|
|St. Michael's Unity Health Toronto||Not yet recruiting|
|Toronto, Ontario, Canada, M5C 2T2|
|Contact: Kenneth Pace, MD 416-867-3695 Kenneth.Pace@unityhealth.to|
|Contact: Daniela Ghiculete, MSc 416-864-6060 Daniela.Ghiculete@unityhealth.to|