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

Part of paid clinical trials in San Diego, California.

Sponsor
SonoMotion
Study ID
NCT03811171
Status
Recruiting
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Conditions

  • Renal Calculi
  • Urinary Calculi

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Break Wave extracorporeal lithotripsy — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 20, 2019
Status verified
Jul 2025
Primary completion
Jan 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    The arm receives the investigational Break Wave procedure.

Primary Outcome Measure

Primary Effectiveness Outcome - Stone Fragmentation [ Time Frame: 12 weeks post-treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California San Diego HealthSan DiegoCalifornia92103-
University of California, San FranciscoSan FranciscoCalifornia94143-
University of Washington Medical CenterSeattleWashington98195-

Find similar trials in San Diego, CA

By research site
University of California San Diego Health· San Diego, CAUniversity of California, San Francisco· San Francisco, CAUniversity of Washington Medical Center· Seattle, WA

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