Renal CalculiNCT03873259
Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)
A study testing Burst Wave Lithotripsy in people with Renal Calculi and Ureteral Calculi, run by University of Washington at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Calculi, Ureteral Calculi
- What is being tested?
- Burst Wave Lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2019to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals presenting with at least one kidney stone apparent on CT
- Individuals scheduled for clinical stone removal via ureteroscopy (URS)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
IU Health North Hospital
Carmel, Indiana, 46032
Kimberly Smoot
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Barbara Burke
About this study
Official title: Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness
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.
Read the 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 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:
- 350 kil0Hertz (kHz) acoustic frequency
- 7 MegaPascals (MPa) 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.
- Conditions
- Renal Calculi, Ureteral Calculi
- Being tested
- Burst Wave Lithotripsy
- Medical subject headings
- Kidney Calculi, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burst Wave LithotripsyDevice
Fragment upper urinary tract stones
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure. Receives: Device: Burst Wave Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Area of Tissue Injury
The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope.
Measured: 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.
Measured: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Secondary outcomes (2)
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
Measured: out to 120 days post-procedure
Effectiveness - Time to Full Comminution
projected time to full comminution defined as the time at which no fragments would be ≤ 2 mm
Measured: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start8 Aug 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal CalculiStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Jonathan Harper, MD, University of Washington
- Investigators
- Michael R Bailey, PhD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873259
- Sponsor's protocol ID
- SITE00000349
- Other IDs
- 5P01DK043881-22
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2019
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28521550Maxwell 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.
PubMed 25111910Bailey 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.
PubMed 35229652Harper 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.
PubMed 32940089
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness
- ClinicalTrials.gov ID
- NCT03873259
- Acronym / sponsor ID
- SITE00000349
- Conditions
- Renal Calculi, Ureteral Calculi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- 350 kil0Hertz (kHz) acoustic frequency
- 7 MegaPascals (MPa) 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Burst Wave LithotripsySubjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals presenting with at least one kidney stone apparent on CT
- Individuals scheduled for clinical stone removal via ureteroscopy (URS)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Burst Wave LithotripsyFragment upper urinary tract stones | Device | Treatment Group |
Primary outcome
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.
2 secondary outcomes
Safety - Adverse Event Assessment
Time frame: out to 120 days post-procedure
Effectiveness - Time to Full Comminution
Time frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 28521550May 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.
- Background: PubMed 25111910Maxwell 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.
- Derived from this study: PubMed 35229652Bailey 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.
- Derived from this study: PubMed 32940089Harper 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.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael R Bailey, PhD, MS principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Burst Wave Lithotripsy in people with Renal Calculi and Ureteral Calculi, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael R Bailey, PhD, MS (206-619-2035, mbailey@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Area of Tissue Injury (time frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03873259, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.