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NCT03873259 · ClinicalTrials.gov registry record · NA
Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)
A NA study of Ureteral Calculi and Renal Calculi, sponsored by University of Washington.
- Active
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT03873259: Active NA study of Ureteral Calculi and Renal Calculi, sponsored by University of Washington.
NCT03873259 is a NA study of Ureteral Calculi and Renal Calculi that is active but no longer recruiting, run by University of Washington. The registered enrollment target is 40 participants, below the 114-participant average among 4 other Ureteral Calculi trials with a reported enrollment target (65% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03873259, a NA study of Ureteral Calculi and Renal Calculi, is active but no longer recruiting, sponsored by University of Washington.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope.
Conditions Studied
Interventions
- DEVICE Burst Wave Lithotripsy
Study Locations (2)
Indiana
- IU Health North Hospital - Carmel
Washington
- University of Washington Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-08-08 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
What the registry record for NCT03873259 still lists
NCT03873259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 114-participant average among 4 other Ureteral Calculi trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Ureteral Calculi appearing as the primary indexed condition, and to 1 intervention - of which Burst Wave Lithotripsy is the first listed.
NCT03873259 reports a single indexed study location in Indiana, Washington.
Frequently Asked Questions
What is clinical trial NCT03873259 about?
NCT03873259 is a clinical study titled "Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)". 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 h...
What is the current status of trial NCT03873259?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2019-08-08. Estimated completion is 2026-04-30.
What conditions does trial NCT03873259 study?
This clinical trial studies the following conditions: Ureteral Calculi, Renal Calculi.
What interventions are being tested in trial NCT03873259?
The interventions under investigation include: Burst Wave Lithotripsy (DEVICE).
Who is sponsoring clinical trial NCT03873259?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03873259 being conducted?
This trial has 2 study locations across Indiana, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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