Safety and Effectiveness of the Ultrasonic Propulsion of Kidney Stones

NCT02028559 | Active Not Recruiting Results DMC

• 1 other identifier: STUDY00002746
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

Brief Summary

This study tests moving kidney stones using focused ultrasound (referred to as ultrasonic propulsion). The study includes multiple population groups to investigate the ability of our technology to: a) move stone fragments to a location within the kidney to improve their chances of passage, and thus reduce the occurrence of additional symptomatic events and retreatment or b) move a symptomatic stone to relieve symptoms and pain.

Conditions

Kidney Stones; Nephrolithiasis; Urolithiasis

Keywords

stones; kidney; stone fragments; lithotripsy

Outcome Measures

Primary Outcomes (3)

• Measurement of Stone Motion Caused by Ultrasound

  Percentage of study participants for which stone motion was observed on the real-time ultrasound images.

  At the time of the procedure. To be evaluated with each therapy pulse over an approximately 1-hour study. Confirmed with post-procedure review of the study video.

• Measurement of Stone Passage

  The percentage of participants reporting visual observation of stone passage or confirmed with follow-up imaging. For the residual fragment RCT population specifically, the percentage of participants reporting visual observation of stone passage during the 3-week follow-up period after the procedure or randomization (Control group).

  Measurement occurs over 3 weeks (weekly phone call or email encounter with the subject) plus review of the subject's medical chart up to the point the subject is exited from the study.

• Measurement of Relapse

  The percentage of participants experiencing stone relapse defined as: an unscheduled, symptomatic visit for stones on the study side, surgery for stones on the study side, or stone growth of a residual fragment measured by clinical imaging exams. This measurement is specific to the residual fragment population and associated randomized control trial. Only a single relapse event is counted per participant, though a participant could experience more than one event.

  Measurement up to 5 years post-procedure. This includes a phone call or email exchange semi-annually for up to 3-years and a medical record review (including imaging) semi-annually for up to 5-years.

Other Outcomes (1)

• Number of Participants With Discomfort Related to the Device or Procedure

  At the time of the procedure. To be evaluated over an approximately 1 hour study.

Study Arms (7)

First in Human (FIH)

EXPERIMENTAL

Initial phase of the trial. Includes a broad spectrum of population groups (e.g. de novo, concurrent with URS, residual fragments) to demonstrate feasibility. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure conducted with the Propulse 1 device and C5-2 transducer. Subjects (n = 15) receive up to 40 push bursts.

Device: Propulse 1 with C5-2 probe

De Novo Small Stone

EXPERIMENTAL

Segment of the trial focused specifically on subjects with small (≤ 5 mm) stones under observation management. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 2) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.

Device: Propulse 1 with SC-X probe

Concurrent with URS

EXPERIMENTAL

Segment of the trial focused specifically on subjects undergoing ultrasonic propulsion concurrently with their ureteroscopy guided laser lithotripsy procedure. Study provides visual observation of stone motion and any potential tissue injury. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 18) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.

Device: Propulse 1 with SC-X probe

Obstructing Stone - Pushing only

EXPERIMENTAL

Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 16) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.

Device: Propulse 1 with SC-X probe

Residual Fragment (Treatment group)

EXPERIMENTAL

Segment of the trial focused specifically on subjects with small (≤ 5 mm) residual fragments following lithotripsy. This is the Treatment arm of a randomized control trial. Intervention consists of the non-invasive application of ultrasound to move stones within the kidney and ureter with the goal to facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 54) receive multiple Push bursts up to a maximum cumulative dose exposure of 5 minutes. Each burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.

Device: Propulse 1 with SC-X probe

Residual Fragment (Control group)

NO INTERVENTION

Segment of the trial focused specifically on subjects with small (≤ 5 mm) residual fragments following lithotripsy. This is the Control arm of a randomized control trial. Subjects (n = 54) follow same protocol as Residual Fragment (Treatment group) but do not receive the ultrasonic propulsion intervention.

Obstructing Stone - Pushing + Dislodging

EXPERIMENTAL

Segment of the trial focused specifically on subjects reporting to clinic or the emergency department with an obstructing stone. Participants were separate from the Obstructing Stone - Pushing only based on a stone skin-to-stone distance \< 8 mm. Intervention consists of the non-invasive application of ultrasound to relieve pain and facilitate passage. Procedure is conducted with the Propulse 1 device and SC-X transducer. Subjects (n = 13) receive both Dislodging and Push bursts up to a maximum cumulative dose exposure of 5 minutes. This is the only population to receive the Dislodging bursts, which consist of higher amplitude (up to 7 MPa) and shorter duration pulses compared to pushing. The Push burst is a maximum of 3 seconds in duration and 200 W/cm2 in intensity.

Device: Propulse 1 with SC-X probe

Interventions

Propulse 1 with C5-2 probe DEVICE

Move kidney stones with Propulse 1 device.

First in Human (FIH)

Propulse 1 with SC-X probe DEVICE

Move kidney stones with Propulse 1 device.

Concurrent with URS; De Novo Small Stone; Obstructing Stone - Pushing + Dislodging; Obstructing Stone - Pushing only; Residual Fragment (Treatment group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals suspected of having at least one kidney stone. This includes:
• Patients who are being managed with watchful waiting or medical therapy
• Patients who recently (but \> 4 weeks) underwent lithotripsy treatment of their stones
• Patients scheduled for lithotripsy treatment
• Individuals suspected of having an obstructed stone. This includes:
• Patients presenting with renal colic
• Patients presenting with hydronephrosis or dilation of the ureter

You may not qualify if:

• Individuals under 18 years of age
• Individuals with non-echogenic stones
• Individuals unable or unwilling to comply with the follow-up requirements
• Individuals with a coagulation abnormality or taking blood thinners or other anticoagulant at clinically significant levels
• Individuals with mobility issues who are unable to comfortably lie for up to 30 minutes or roll from their back to their side
• Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
• Individuals who have already received four previous ultrasonic propulsion procedures.
• Individuals who have received an ultrasonic propulsion treatment within the last 4 weeks.
• Individuals with a suspicion of kidney infection or exhibiting signs of sepsis
• Individuals whom the treating physician considers to be at high risk for serious alternate diagnoses such as acute infectious etiologies (e.g. cholecystitis, appendicitis), aortic aneurysm and rupture, or bowel disorders.
• Individuals who have undergone renal transplant, or individuals who will undergo dialysis.
• Individuals with bilateral hydronephrosis
• Individuals with a single kidney
• Individuals who have already received an ultrasonic propulsion investigative treatment for the same obstructing stone

Sponsors & Collaborators

• University of Washington: lead
• VA Puget Sound Health Care System: collaborator

Study Sites (2)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

University of Washington Department of Urology

Seattle, Washington, 98195, United States

Location

Related Publications (6)

• Hall 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.

  PMID: 36205340 RESULT

• Dai 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.

  PMID: 31333058 RESULT

• Harper 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.

  PMID: 26521719 RESULT

• Sorensen 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.

  PMID: 39146526 RESULT

• Yang CC, Keating EE, Managuli R, Honssinger N, Holt SK, Desai AC. A Randomized Controlled Trial of Ultrasonic Propulsion-Facilitated Clearance of Residual Renal Stone Fragments vs Observation. J Urol. 2025 Jul;214(1):3-9. doi: 10.1097/JU.0000000000004501. Epub 2025 Mar 3.

  PMID: 40030414 RESULT

• 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.

  PMID: 32940089 DERIVED

Related Links

• Link to a page at the University of Washingon Applied Physics Laboratory website that provides additional information on ultrasonic propulsion.

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis; Urolithiasis; Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michael Bailey
• Organization: University of Washington

mbailey@uw.edu

206 - 685 - 8618

Study Officials

• Jonathan Harper, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessors evaluating: a) imaging for stone growth, b) relatedness of safety events to the device/procedure or underlying stone condition, and c) relapse events, for the residual fragment (RCT) population are blind to the exposure condition.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Urology

Model Details: Population groups 1-4 are single groups. Subjects are assigned based upon their underlying stone condition and the stage of the trial. Subjects enrolled into the residual fragment population (group 5) are randomized between a treatment group and concurrent control group.

Study Record Dates

• First Submitted: January 1, 2014
• First Posted: January 7, 2014
• Study Start: December 17, 2013
• Primary Completion: August 1, 2025
• Study Completion: May 31, 2026
• Last Updated: June 1, 2026
• Results First Posted: June 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)