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

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

August 20, 2019

Primary Completion Date

January 30, 2027

Study Completion Date

March 30, 2027

Conditions
Renal CalculiUrinary Calculi
Interventions
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.

Trial Locations (6)

92103

COMPLETED

University of California San Diego Health, San Diego

94143

COMPLETED

University of California, San Francisco, San Francisco

98195

COMPLETED

University of Washington Medical Center, Seattle

T6G1Z1

COMPLETED

University of Alberta, Division of Urology, Edmonton

BC V5Z 1M9

RECRUITING

Vancouver General Hospital Stone Centre, Vancouver

M5C 2T2

NOT_YET_RECRUITING

St. Michael's Unity Health Toronto, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

SonoMotion

INDUSTRY

NCT03811171 - Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study | Biotech Hunter | Biotech Hunter