Ultrasound to Facilitate Stone Passage

NCT04796792 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY000116875P01DK043881-26
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Urinary Stone; Urinary Calculi

Outcome Measures

Primary Outcomes (2)

• Safety - incidence of return healthcare visits.

  Incidence of return health care visits associated with the device or procedure.

  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.

  Day of procedure to 4 months posts procedure

Secondary Outcomes (4)

• Safety - incidence of adverse events (AEs)

  Day of procedure to 4 months posts procedure

• Effectiveness - % residual stone volume

  Day of procedure to 4 months posts procedure

• Effectiveness - need for further stone management

  Day of procedure to 4 months posts procedure

• Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire

  Day of procedure to 14 months posts procedure

Study Arms (4)

Phase I: Feasibility Treatment group

EXPERIMENTAL

Initial phase of the trial to demonstrate feasibility. All subjects undergo the investigational intervention.

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.

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.

Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)

Interventions

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.

Phase 2a: Treatment Group of a randomized control trial; Phase 2b: Spinal Cord Injury Feasibility Study; Phase I: Feasibility Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Washington: lead
• Indiana University: collaborator
• VA Puget Sound Health Care System: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Indiana University Health - North Hospital

Carmel, Indiana, 46032, United States

WITHDRAWN

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 28521550 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.

  PMID: 25111910 BACKGROUND

• 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 BACKGROUND

• Ramesh 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.

  PMID: 32103689 BACKGROUND

• 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 BACKGROUND

• Maxwell 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.

  PMID: 31016998 BACKGROUND

• 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 BACKGROUND

• Harper 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.

  PMID: 35311351 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Shelton 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.

  PMID: 39819022 BACKGROUND

• Harper 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.

  PMID: 40096677 RESULT

Related Links

• Sponsor website

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan Harper, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Bailey, PhD

CONTACT

206-619-2035; mbailey@uw.edu

Barbrina Dunmire, MS

CONTACT

mrbean@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 15, 2021
• Study Start: April 1, 2023
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)