Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)
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|ClinicalTrials.gov Identifier: NCT03873259|
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Renal Calculi Ureteral Calculi||Device: Burst Wave Lithotripsy||Not Applicable|
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 Clinic.
The investigative study will be performed in the operating room prior to a standard-of-care (SoC) ureteroscopic (URS) laser lithotripsy procedure. The subject will already be under anesthesia. Stones will be limited to ≤7 mm.
The study has one (treatment) arm consisting of 20 subjects. All subjects will be treated with the same output parameters for up to a maximum of 10 minutes per stone. The output parameters are nominally defined as:
- 350 kHz acoustic frequency
- 6 MPa maximum peak negative pressure
- 20 cycle pulse duration
- 17 Hz pulse repetition frequency
A maximum of 3 stones can be treated per subject.
Safety will be monitored by visual observation of the tissue with an ureteroscopic camera, the self-reported occurrences of adverse events, and occurrences of unplanned emergency department or clinic visits. Fragmentation will be measured by visual observation with an ureteroscopic camera and direct measure of stones removed by basket after the procedure.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Outcomes assessors will be blinded to the treatment conditions. This will include review of video data for tissue injury.|
|Official Title:||Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||April 30, 2022|
Experimental: Treatment Group
Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.
Device: Burst Wave Lithotripsy
Fragment upper urinary tract stones
- Safety - Area of Tissue Injury [ Time Frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure. ]The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope.
- Effectiveness - Volume of Fragments < 2 mm [ Time Frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure. ]The primary effectiveness endpoint is the volume fraction of stone fragments less than 2 mm relative to the original stone volume.
- Safety - Adverse Event Assessment [ Time Frame: out to 120 days post-procedure ]The secondary safety outcome is the documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events typically associated with shock wave lithotripsy (SWL) and URS
- Effectiveness - Time to Full Comminution [ Time Frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure. ]projected time to full comminution defined as the time at which no fragments would be ≤ 2 mm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873259
|Contact: Michael R Bailey, PhD, MSemail@example.com|
|Contact: Barbrina Dunmirefirstname.lastname@example.org|
|Principal Investigator:||Michael R Bailey, PhD, MS||University of Washington|