Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

Part of paid clinical trials in Carmel, Indiana.

Sponsor
University of Washington
Study ID
NCT03873259
Status
Recruiting
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Conditions

  • Renal Calculi
  • Ureteral Calculi

Eligibility Criteria

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

Interventions

  • Burst Wave Lithotripsy — DEVICE
    Fragment upper urinary tract stones

Study Details

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.

Key Dates

Start date
Aug 8, 2019
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

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

Arms

  • Experimental: Treatment Group
    Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.

Primary Outcome Measure

Safety - Area of Tissue Injury [ Time Frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
IU Health North HospitalCarmelIndiana46032
Kimberly Smoot
University of Washington Medical CenterSeattleWashington98195
Barbara Burke

Find similar trials in Carmel, IN

By research site
IU Health North Hospital· Carmel, INUniversity of Washington Medical Center· Seattle, WA

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