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| ID | Type | Description | Link |
|---|---|---|---|
| 5P01DK043881-22 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Indiana University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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 ≤ 12 mm.
The study has one (treatment) arm and is approved to enroll up to 40 subjects (with the intent to treat 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Burst Wave Lithotripsy | Device | Fragment upper urinary tract stones |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Area of Tissue Injury | The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope. | Day 0 - the day of the experimental procedure immediately following the acoustic procedure. |
| Effectiveness - Volume of Fragments < 2 mm | The primary effectiveness endpoint is the volume fraction of stone fragments less than 2 mm relative to the original stone volume. | Day 0 - the day of the experimental procedure immediately following the acoustic procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Adverse Event Assessment | 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 | out to 120 days post-procedure |
| Effectiveness - Time to Full Comminution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael R Bailey, PhD, MS | Contact | 206-619-2035 | mbailey@uw.edu | |
| Barbrina Dunmire | Contact | 206-769-5910 | mrbean@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael R Bailey, PhD, MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health North Hospital | Recruiting | Carmel | Indiana | 46032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28521550 | Background | May PC, Kreider W, Maxwell AD, Wang YN, Cunitz BW, Blomgren PM, Johnson CD, Park JSH, Bailey MR, Lee D, Harper JD, Sorensen MD. Detection and Evaluation of Renal Injury in Burst Wave Lithotripsy Using Ultrasound and Magnetic Resonance Imaging. J Endourol. 2017 Aug;31(8):786-792. doi: 10.1089/end.2017.0202. Epub 2017 Jun 16. | |
| 25111910 | Background | Maxwell AD, Cunitz BW, Kreider W, Sapozhnikov OA, Hsi RS, Harper JD, Bailey MR, Sorensen MD. Fragmentation of urinary calculi in vitro by burst wave lithotripsy. J Urol. 2015 Jan;193(1):338-44. doi: 10.1016/j.juro.2014.08.009. Epub 2014 Aug 9. |
| Label | URL |
|---|---|
| Sponsor Website | View source |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D014514 | Ureteral Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Some outcomes assessors will be blinded to the treatment conditions. This will include review of video data for tissue injury.
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projected time to full comminution defined as the time at which no fragments would be ≤ 2 mm |
| Day 0 - the day of the experimental procedure immediately following the acoustic procedure. |
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98195 | United States |
|
| 35229652 | Derived | Bailey MR, Maxwell AD, Cao S, Ramesh S, Liu Z, Williams JC, Thiel J, Dunmire B, Colonius T, Kuznetsova E, Kreider W, Sorensen MD, Lingeman JE, Sapozhnikov OA. Improving Burst Wave Lithotripsy Effectiveness for Small Stones and Fragments by Increasing Frequency: Theoretical Modeling and Ex Vivo Study. J Endourol. 2022 Jul;36(7):996-1003. doi: 10.1089/end.2021.0714. Epub 2022 Jun 22. |
| 32940089 | Derived | Harper JD, Metzler I, Hall MK, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Thiel J, Williams JC, Bailey MR, Sorensen MD. First In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies. J Endourol. 2021 Apr;35(4):506-511. doi: 10.1089/end.2020.0725. Epub 2020 Nov 5. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |