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

Not Applicable

Active, not recruiting

• Conditions: Urinary Calculi; Renal Calculi

• Registration Number: NCT03811171
• Lead Sponsor: SonoMotion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-22
• Study Start: 2019-08-20
• Primary Completion: 2024-01-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Secondary effectiveness outcome - Stone Free Status	12 weeks post-treatment	Radiographic evidence (CT imaging) of stone free status.

Trial Locations

Locations (6)

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, United States

University of Alberta, Division of Urology; 🇨🇦 Edmonton, Alberta, Canada

Vancouver General Hospital Stone Centre; 🇨🇦 Vancouver, British Columbia, Canada

St. Michael's Unity Health Toronto; 🇨🇦 Toronto, Ontario, Canada