Status:
ACTIVE_NOT_RECRUITING
Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Indiana University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Renal Calculi
Ureteral Calculi
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 extr...
Detailed Description
This is a two-center, single-arm, feasibility study. The two centers are located within the US and include: University of Washington (UW) School of Medicine and Indiana University (IU) Health Urology ...
Eligibility Criteria
Inclusion
- Individuals presenting with at least one kidney stone apparent on CT
- Individuals scheduled for clinical stone removal via ureteroscopy (URS)
Exclusion
- 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
Key Trial Info
Start Date :
August 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03873259
Start Date
August 8 2019
End Date
April 30 2026
Last Update
July 10 2025
Active Locations (2)
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1
IU Health North Hospital
Carmel, Indiana, United States, 46032
2
University of Washington Medical Center
Seattle, Washington, United States, 98195