Urinary StoneNCT04796792
Ultrasound to Facilitate Stone Passage
A study testing Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP) in people with Urinary Stone and Urinary Calculi, run by University of Washington at 3 sites in United States.
Trial summary
This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Stone, Urinary Calculi
- What is being tested?
- Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2023to 31 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals presenting with at least one kidney stone
- Stone with maximum dimension > 2 mm and ≤ 7 mm as determined by clinical imaging
- Individuals with SCI - (Phase 2b only)
Who cannot join
- Individuals under 18 years of age
- Individuals who are pregnant or who are trying to get pregnant
- Prisoners
- with cognitive impairment that would limit their ability to comprehend their role in consent or participation.
- Individuals who are unable to read or understand English
- Individuals who are unable or unwilling to participate in follow up activities
Show all 16Show fewer
- Individuals who cannot be positioned for ultrasound imaging
- Individuals with uncorrected bleeding disorders or coagulopathies
- Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure
- Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure
- Individuals with a solitary kidney
- Individuals with an uncorrected urinary tract obstruction
- Individuals with an untreated infection
- Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure
- Individuals who have received two previous investigational procedures for the same stone target
- Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Barbrina Dunmire, MS contact
United States3 sites, 2 recruiting
- Withdrawn
Indiana University Health - North Hospital
Carmel, Indiana, 46032
- Recruiting
VA Puget Sound Health Care System
Seattle, Washington, 98108
Branda Levchak, branda.levchak@va.gov
Claire Yang, MD
- Recruiting
University of Washington
Seattle, Washington, 98195
Michael Bailey, PhD, 206-619-2035, mbailey@uw.edu
Barbara Burke, burkeb3@uw.edu
About this study
Official title: Ultrasound Technology to Fragment and Reposition Urinary Stones
This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.
Read the detailed description
This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.
Subjects will be included across three phases:
- Phase 1: 20 subjects to demonstrate initial feasibility
- Phase 2a: 100 subjects for a two-arm (50:50) randomized control trial (RCT)
- Phase 2b: 20 subjects to demonstrate feasibility in individuals with spinal cord injury (SCI)
This study has completed Phase 1. The study is currently recruiting for Phase 2b. Recruitment has not yet started for Phase 2a.
Up to 3 distinct targets may be treated per subject. The maximum total dose exposure is 30 minutes for one session. Subjects may return after at least 21 days and after all AEs have resolved for an additional session on the same side. Subjects may return after imaging follow-up for inclusion of their contralateral side.
- Conditions
- Urinary Stone, Urinary Calculi
- Being tested
- Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)Device
Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short 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. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Feasibility Treatment group | Experimental | Initial phase of the trial to demonstrate feasibility. All subjects undergo the investigational intervention. Receives: Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP) |
| Phase 2a: Treatment Group of a randomized control trial | Experimental | RCT phase of the trial to demonstrate superiority. All subjects undergo the investigational intervention. Receives: Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP) |
| Phase 2a: Control group of a randomized control trial | No intervention | RCT phase of the trial to demonstrate superiority. All subjects are the concurrent Control to the Phase 2a Treatment group. Subjects receive no intervention. |
| Phase 2b: Spinal Cord Injury Feasibility Study | Experimental | Feasbility study of the investigational intervention in subjects with spinal cord injury. Receives: Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - incidence of return healthcare visits.
Incidence of return health care visits associated with the device or procedure.
Measured: Day of procedure to 14 months post-procedure
Effectiveness - stone comminution into fragments 2 mm or less.
Number of cases where the largest dimension of any residual stone in the study kidney is less than or equal to 2 mm.
Measured: Day of procedure to 4 months posts procedure
Secondary outcomes (4)
Safety - incidence of adverse events (AEs)
The incidence of all adverse events (AEs) associated with the device or procedure
Measured: Day of procedure to 4 months posts procedure
Effectiveness - % residual stone volume
Residual stone volume relative to the initial stone volume
Measured: Day of procedure to 4 months posts procedure
Effectiveness - need for further stone management
Incidence of new healthcare visits for further stone management
Measured: Day of procedure to 4 months posts procedure
Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire
Quality of life, evaluated by the comparison of Wisconsin Stone Quality of Life (WISQOL) questionnaire scores before and after the investigational procedure. The questionnaire consists of a series of questions to evaluate the symptomatic and functional impact of the stones on a scale of 1 to 5, where a lower score indicates a greater impact. https://urology.wisc.edu/research/wisqol/.
Measured: Day of procedure to 14 months posts procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Apr 2023
- Primary completion31 May 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Urinary StoneStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Each phase represents a different population group. Phase 2a includes a randomized control component; the treatment and control groups are listed as separate arms with non-randomized allocation for consistency.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, VA Puget Sound Health Care System, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Jonathan Harper, MD, University of Washington
- Investigators
- Jonathan Harper, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796792
- Sponsor's protocol ID
- STUDY00011687
- Other IDs
- 5P01DK043881-26
- Status last verified
- Dec 2025
- First submitted
- 3 Mar 2021
- Last updated
- 9 Dec 2025
- 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 25111910Harper 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 32940089Ramesh S, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Thiel J, Williams JC, Gardner A, Liu Z, Metzler I, Harper JD, Sorensen MD, Bailey MR. In Vitro Evaluation of Urinary Stone Comminution with a Clinical Burst Wave Lithotripsy System. J Endourol. 2020 Nov;34(11):1167-1173. doi: 10.1089/end.2019.0873. Epub 2020 Mar 20.
PubMed 32103689Dai JC, Sorensen MD, Chang HC, Samson PC, Dunmire B, Cunitz BW, Thiel J, Liu Z, Bailey MR, Harper JD. Quantitative Assessment of Effectiveness of Ultrasonic Propulsion of Kidney Stones. J Endourol. 2019 Oct;33(10):850-857. doi: 10.1089/end.2019.0340. Epub 2019 Sep 25.
PubMed 31333058Maxwell AD, Wang YN, Kreider W, Cunitz BW, Starr F, Lee D, Nazari Y, Williams JC Jr, Bailey MR, Sorensen MD. Evaluation of Renal Stone Comminution and Injury by Burst Wave Lithotripsy in a Pig Model. J Endourol. 2019 Oct;33(10):787-792. doi: 10.1089/end.2018.0886. Epub 2019 May 27.
PubMed 31016998Harper JD, Cunitz BW, Dunmire B, Lee FC, Sorensen MD, Hsi RS, Thiel J, Wessells H, Lingeman JE, Bailey MR. First in Human Clinical Trial of Ultrasonic Propulsion of Kidney Stones. J Urol. 2016 Apr;195(4 Pt 1):956-64. doi: 10.1016/j.juro.2015.10.131. Epub 2015 Oct 30.
PubMed 26521719Harper JD, Lingeman JE, Sweet RM, Metzler IS, Sunaryo PL, Williams JC Jr, Maxwell AD, Thiel J, Cunitz BW, Dunmire B, Bailey MR, Sorensen MD. Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans. J Urol. 2022 May;207(5):1067-1076. doi: 10.1097/JU.0000000000002446. Epub 2022 Mar 21.
PubMed 35311351Hall MK, Thiel J, Dunmire B, Samson PC, Kessler R, Sunaryo P, Sweet RM, Metzler IS, Chang HC, Gunn M, Dighe M, Anderson L, Popchoi C, Managuli R, Cunitz BW, Burke BH, Ding L, Gutierrez B, Liu Z, Sorensen MD, Wessells H, Bailey MR, Harper JD. First Series Using Ultrasonic Propulsion and Burst Wave Lithotripsy to Treat Ureteral Stones. J Urol. 2022 Nov;208(5):1075-1082. doi: 10.1097/JU.0000000000002864. Epub 2022 Nov 1.
PubMed 36205340Sorensen MD, Dunmire B, Thiel J, Cunitz BW, Burke BH, Levchak BJ, Popchoi C, Holmes AE, Kucewicz JC, Hall MK, Dighe M, Dai JC, Cormack FC, Liu Z, Bailey MR, Porter MP, Harper JD. Randomized Controlled Trial of Ultrasonic Propulsion-Facilitated Clearance of Residual Kidney Stone Fragments vs Observation. J Urol. 2024 Dec;212(6):811-820. doi: 10.1097/JU.0000000000004186. Epub 2024 Aug 15.
PubMed 39146526Shelton TM, Connors BA, Rivera ME, Lingeman JE, Bailey MR, Williams JC Jr. No Injury Observed in Kidneys Treated with Burst Wave Lithotripsy in Therapeutically Anticoagulated Pigs. J Endourol. 2025 Aug;39(8):804-807. doi: 10.1089/end.2024.0466. Epub 2025 Jan 16.
PubMed 39819022Harper JD, Dunmire B, Thiel J, Burke BH, Wang YN, Totten S, Kucewicz JC, Maxwell AD, Hall MK, Holmes AE, Popchoi C, Lingeman JE, Desai AC, Sweet RM, Dighe M, Levchak BJ, Yang CC, Bailey MR, Sorensen MD. Facilitated Clearance of Small, Asymptomatic Renal Stones With Burst Wave Lithotripsy and Ultrasonic Propulsion. J Urol. 2025 Jul;214(1):41-47. doi: 10.1097/JU.0000000000004533. Epub 2025 Mar 17.
PubMed 40096677
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Technology to Fragment and Reposition Urinary Stones
- ClinicalTrials.gov ID
- NCT04796792
- Acronym / sponsor ID
- STUDY00011687
- Conditions
- Urinary Stone, Urinary Calculi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Indiana University, VA Puget Sound Health Care System, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 15 Mar 2021 (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.
This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.
Detailed description
This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.
Subjects will be included across three phases:
- Phase 1: 20 subjects to demonstrate initial feasibility
- Phase 2a: 100 subjects for a two-arm (50:50) randomized control trial (RCT)
- Phase 2b: 20 subjects to demonstrate feasibility in individuals with spinal cord injury (SCI)
This study has completed Phase 1. The study is currently recruiting for Phase 2b. Recruitment has not yet started for Phase 2a.
Up to 3 distinct targets may be treated per subject. The maximum total dose exposure is 30 minutes for one session. Subjects may return after at least 21 days and after all AEs have resolved for an additional session on the same side. Subjects may return after imaging follow-up for inclusion of their contralateral side.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Each phase represents a different population group. Phase 2a includes a randomized control component; the treatment and control groups are listed as separate arms with non-randomized allocation for consistency.
| Arm | Type | Receives |
|---|---|---|
| Phase I: Feasibility Treatment group | Experimental | Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)Initial phase of the trial to demonstrate feasibility. All subjects undergo the investigational intervention. |
| Phase 2a: Treatment Group of a randomized control trial | Experimental | Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)RCT phase of the trial to demonstrate superiority. All subjects undergo the investigational intervention. |
| Phase 2a: Control group of a randomized control trial | No intervention | –RCT phase of the trial to demonstrate superiority. All subjects are the concurrent Control to the Phase 2a Treatment group. Subjects receive no intervention. |
| Phase 2b: Spinal Cord Injury Feasibility Study | Experimental | Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)Feasbility study of the investigational intervention in subjects with spinal cord injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals presenting with at least one kidney stone
- Stone with maximum dimension > 2 mm and ≤ 7 mm as determined by clinical imaging
- Individuals with SCI - (Phase 2b only)
Key exclusion criteria (16 listed)
- Individuals under 18 years of age
- Individuals who are pregnant or who are trying to get pregnant
- Prisoners
- with cognitive impairment that would limit their ability to comprehend their role in consent or participation.
- Individuals who are unable to read or understand English
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 Lithotripsy (BWL) and Ultrasonic Propulsion (UP)Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short 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. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system. | Device | Phase 2a: Treatment Group of a randomized control trial, Phase 2b: Spinal Cord Injury Feasibility Study, Phase I: Feasibility Treatment group |
Primary outcome
Safety - incidence of return healthcare visits.
Time frame: Day of procedure to 14 months post-procedure
Incidence of return health care visits associated with the device or procedure.
Effectiveness - stone comminution into fragments 2 mm or less.
Time frame: Day of procedure to 4 months posts procedure
Number of cases where the largest dimension of any residual stone in the study kidney is less than or equal to 2 mm.
4 secondary outcomes
Safety - incidence of adverse events (AEs)
Time frame: Day of procedure to 4 months posts procedure
Effectiveness - % residual stone volume
Time frame: Day of procedure to 4 months posts procedure
Effectiveness - need for further stone management
Time frame: Day of procedure to 4 months posts procedure
Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire
Time frame: Day of procedure to 14 months posts 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 9 Dec 2025.
- 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.
- Background: 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.
- Background: PubMed 32103689Ramesh S, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Thiel J, Williams JC, Gardner A, Liu Z, Metzler I, Harper JD, Sorensen MD, Bailey MR. In Vitro Evaluation of Urinary Stone Comminution with a Clinical Burst Wave Lithotripsy System. J Endourol. 2020 Nov;34(11):1167-1173. doi: 10.1089/end.2019.0873. Epub 2020 Mar 20.
- Background: PubMed 31333058Dai JC, Sorensen MD, Chang HC, Samson PC, Dunmire B, Cunitz BW, Thiel J, Liu Z, Bailey MR, Harper JD. Quantitative Assessment of Effectiveness of Ultrasonic Propulsion of Kidney Stones. J Endourol. 2019 Oct;33(10):850-857. doi: 10.1089/end.2019.0340. Epub 2019 Sep 25.
- Background: PubMed 31016998Maxwell AD, Wang YN, Kreider W, Cunitz BW, Starr F, Lee D, Nazari Y, Williams JC Jr, Bailey MR, Sorensen MD. Evaluation of Renal Stone Comminution and Injury by Burst Wave Lithotripsy in a Pig Model. J Endourol. 2019 Oct;33(10):787-792. doi: 10.1089/end.2018.0886. Epub 2019 May 27.
- Background: PubMed 26521719Harper JD, Cunitz BW, Dunmire B, Lee FC, Sorensen MD, Hsi RS, Thiel J, Wessells H, Lingeman JE, Bailey MR. First in Human Clinical Trial of Ultrasonic Propulsion of Kidney Stones. J Urol. 2016 Apr;195(4 Pt 1):956-64. doi: 10.1016/j.juro.2015.10.131. Epub 2015 Oct 30.
- Background: PubMed 35311351Harper JD, Lingeman JE, Sweet RM, Metzler IS, Sunaryo PL, Williams JC Jr, Maxwell AD, Thiel J, Cunitz BW, Dunmire B, Bailey MR, Sorensen MD. Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans. J Urol. 2022 May;207(5):1067-1076. doi: 10.1097/JU.0000000000002446. Epub 2022 Mar 21.
- Background: PubMed 36205340Hall MK, Thiel J, Dunmire B, Samson PC, Kessler R, Sunaryo P, Sweet RM, Metzler IS, Chang HC, Gunn M, Dighe M, Anderson L, Popchoi C, Managuli R, Cunitz BW, Burke BH, Ding L, Gutierrez B, Liu Z, Sorensen MD, Wessells H, Bailey MR, Harper JD. First Series Using Ultrasonic Propulsion and Burst Wave Lithotripsy to Treat Ureteral Stones. J Urol. 2022 Nov;208(5):1075-1082. doi: 10.1097/JU.0000000000002864. Epub 2022 Nov 1.
- Background: PubMed 39146526Sorensen MD, Dunmire B, Thiel J, Cunitz BW, Burke BH, Levchak BJ, Popchoi C, Holmes AE, Kucewicz JC, Hall MK, Dighe M, Dai JC, Cormack FC, Liu Z, Bailey MR, Porter MP, Harper JD. Randomized Controlled Trial of Ultrasonic Propulsion-Facilitated Clearance of Residual Kidney Stone Fragments vs Observation. J Urol. 2024 Dec;212(6):811-820. doi: 10.1097/JU.0000000000004186. Epub 2024 Aug 15.
- Background: PubMed 39819022Shelton TM, Connors BA, Rivera ME, Lingeman JE, Bailey MR, Williams JC Jr. No Injury Observed in Kidneys Treated with Burst Wave Lithotripsy in Therapeutically Anticoagulated Pigs. J Endourol. 2025 Aug;39(8):804-807. doi: 10.1089/end.2024.0466. Epub 2025 Jan 16.
- Results publication: PubMed 40096677Harper JD, Dunmire B, Thiel J, Burke BH, Wang YN, Totten S, Kucewicz JC, Maxwell AD, Hall MK, Holmes AE, Popchoi C, Lingeman JE, Desai AC, Sweet RM, Dighe M, Levchak BJ, Yang CC, Bailey MR, Sorensen MD. Facilitated Clearance of Small, Asymptomatic Renal Stones With Burst Wave Lithotripsy and Ultrasonic Propulsion. J Urol. 2025 Jul;214(1):41-47. doi: 10.1097/JU.0000000000004533. Epub 2025 Mar 17.
- 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.
Barbrina Dunmire, MS contact
Jonathan Harper, MD principal investigator
University of Washington
3 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 (BWL) and Ultrasonic Propulsion (UP) in people with Urinary Stone and Urinary Calculi, run by University of Washington at 3 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 3 inclusion and 16 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 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Bailey, PhD (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 - incidence of return healthcare visits. (time frame: Day of procedure to 14 months post-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 NCT04796792, which also lists 12 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 9 Dec 2025.