Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study

Renal Calculi Clinical Trial

Official title:

A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03811171
• Other study ID #: CLP-0001
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: SonoMotion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Calculi
• Urinary Calculi
• Urolithiasis

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Alberta, Division of Urology	Edmonton	Alberta
Canada	St. Michael's Unity Health Toronto	Toronto	Ontario
Canada	Vancouver General Hospital Stone Centre	Vancouver	British Columbia
United States	University of California San Diego Health	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
SonoMotion

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (4)

Harper JD, Lingeman JE, Sweet RM, Metzler IS, Sunaryo PL, Williams JC Jr, Maxwell AD, Thiel J, Cunitz BW, Dunmire B, Bailey MR, Sorensen MD. Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans. J Urol. 2022 May;207(5):1067-1076. doi: 10.1097/JU.0000000000002446. Epub 2022 Mar 21. — View Citation

Maxwell AD, Cunitz BW, Kreider W, Sapozhnikov OA, Hsi RS, Harper JD, Bailey MR, Sorensen MD. Fragmentation of urinary calculi in vitro by burst wave lithotripsy. J Urol. 2015 Jan;193(1):338-44. doi: 10.1016/j.juro.2014.08.009. Epub 2014 Aug 9. — View Citation

Maxwell AD, MacConaghy B, Bailey MR, Sapozhnikov OA. An investigation of elastic waves producing stone fracture in burst wave lithotripsy. J Acoust Soc Am. 2020 Mar;147(3):1607. doi: 10.1121/10.0000847. — View Citation

Sapozhnikov OA, Maxwell AD, Bailey MR. Modeling of photoelastic imaging of mechanical stresses in transparent solids mimicking kidney stones. J Acoust Soc Am. 2020 Jun;147(6):3819. doi: 10.1121/10.0001386. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Outcome - Stone Fragmentation	Stone fragmentation as determined by stone passage or imaging confirmation.	12 weeks post-treatment
Primary	Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia	The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.	12 weeks post-treatment
Secondary	Secondary effectiveness outcome - Stone Free Status	Radiographic evidence (CT imaging) of stone free status.	12 weeks post-treatment
Secondary	Secondary effectiveness outcome - Residual fragment size	Presence of only stone fragments small enough to pass (less than or equal to 4 mm).	12 weeks post-treatment
Secondary	Secondary safety outcome - Adverse events	documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events associated with shock wave lithotripsy (SWL)	12 weeks post-treatment

External Links

•   Sponsor Website