Active — Not RecruitingNot Applicable

Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

United States40 participantsStarted 2019-08-08

Plain-language summary

Burst Wave Lithotripsy (BWL) is a novel method of urinary stone fragmentation that uses multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. This is a single-arm feasibility study to test the ability of BWL to comminute (fragment) stones in humans.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals presenting with at least one kidney stone apparent on CT * Individuals scheduled for clinical stone removal via ureteroscopy (URS) Exclusion Criteria: * Individuals under 18 years of age * Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.) * Individuals with uncorrected bleeding disorders or coagulopathies * Individuals taking a clinically significant anticoagulant dose at the time of the procedure * Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm * Individuals with a solitary kidney * Individuals with a comorbidity risks which, at the discretion of the physician, would make the patient a poor candidate for the BWL procedure

What they're measuring

Safety - Area of Tissue Injury

Timeframe: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.

Effectiveness - Volume of Fragments < 2 mm

Timeframe: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.

Trial details

NCT IDNCT03873259

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31