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

Sponsor

SonoMotion (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03811171

Collaborator

(none)

Enrollment

Locations

Arm

46.3

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Calculi Urinary Calculi	Device: Break Wave extracorporeal lithotripsy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 20, 2019

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment 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.

Arm

Intervention/Treatment

Experimental: Treatment

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.

Outcome Measures

Primary Outcome Measures

Primary Effectiveness Outcome - Stone Fragmentation [12 weeks post-treatment]
Stone fragmentation as determined by stone passage or imaging confirmation.
Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia [12 weeks post-treatment]
The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.

Secondary Outcome Measures

Secondary effectiveness outcome - Stone Free Status [12 weeks post-treatment]
Radiographic evidence (CT imaging) of stone free status.
Secondary effectiveness outcome - Residual fragment size [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego Health	San Diego	California	United States	92103
2	University of California, San Francisco	San Francisco	California	United States	94143
3	University of Washington Medical Center	Seattle	Washington	United States	98195
4	University of Alberta, Division of Urology	Edmonton	Alberta	Canada	T6G1Z1
5	Vancouver General Hospital Stone Centre	Vancouver	British Columbia	Canada	BC V5Z 1M9
6	St. Michael's Unity Health Toronto	Toronto	Ontario	Canada	M5C 2T2