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Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

NCT03873259 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Renal Calculi
  • Ureteral Calculi

Interventions

DEVICE

Burst Wave Lithotripsy

Fragment upper urinary tract stones

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Michael R Bailey, PhD, MS · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-08
Primary Completion
2027-12-31
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03873259 on ClinicalTrials.gov