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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
University of California San Diego Health
COMPLETED
San Diego
University of California, San Francisco
COMPLETED
San Francisco
Washington
University of Washington Medical Center
COMPLETED
Seattle
Other Locations
Canada
University of Alberta, Division of Urology
COMPLETED
Edmonton
St. Michael's Unity Health Toronto
NOT_YET_RECRUITING
Toronto
Vancouver General Hospital Stone Centre
RECRUITING
Vancouver
Contact Information
Primary
Oren Levy, PhD
oren.levy@sonomotion.com
4156722631
Time Frame
Start Date: 2019-08-20
Estimated Completion Date: 2027-03-30
Participants
Target number of participants: 70
Treatments
Experimental: Treatment
The arm receives the investigational Break Wave procedure.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: SonoMotion

This content was sourced from clinicaltrials.gov