Ultrasound to Facilitate Stone Passage

Part of paid clinical trials in Carmel, Indiana.

Sponsor
University of Washington
Study ID
NCT04796792
Status
Recruiting
Apply to this trial

Conditions

  • Urinary Calculi
  • Urinary Stone

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP) — DEVICE
    Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short 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. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.

Study Details

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

Key Dates

Start date
Apr 1, 2023
Status verified
Dec 2025
Primary completion
May 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Feasibility Treatment group
    Initial phase of the trial to demonstrate feasibility. All subjects undergo the investigational intervention.
  • Experimental: Phase 2a: Treatment Group of a randomized control trial
    RCT phase of the trial to demonstrate superiority. All subjects undergo the investigational intervention.
  • No Intervention: Phase 2a: Control group of a randomized control trial
    RCT phase of the trial to demonstrate superiority. All subjects are the concurrent Control to the Phase 2a Treatment group. Subjects receive no intervention.
  • Experimental: Phase 2b: Spinal Cord Injury Feasibility Study
    Feasbility study of the investigational intervention in subjects with spinal cord injury.

Primary Outcome Measure

Safety - incidence of return healthcare visits. [ Time Frame: Day of procedure to 14 months post-procedure ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana University Health - North HospitalCarmelIndiana46032-
University of WashingtonSeattleWashington98195
Michael Bailey, PhD
[email protected]
206-619-2035
Barbara Burke
[email protected]
Jonathan Harper, MD (PRINCIPAL_INVESTIGATOR)
VA Puget Sound Health Care SystemSeattleWashington98108
Branda Levchak
[email protected]
Claire Yang, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Carmel, IN

By research site
Indiana University Health - North Hospital· Carmel, INUniversity of Washington· Seattle, WAVA Puget Sound Health Care System· Seattle, WA

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