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NCT Number: NCT04796792

Ultrasound to Facilitate Stone Passage

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health - North Hospital, Carmel, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Safety - incidence of adverse events (AEs)

    Time frame: Day of procedure to 4 months posts procedure

    The incidence of all adverse events (AEs) associated with the device or procedure

  2. Effectiveness - % residual stone volume

    Time frame: Day of procedure to 4 months posts procedure

    Residual stone volume relative to the initial stone volume

  3. Effectiveness - need for further stone management

    Time frame: Day of procedure to 4 months posts procedure

    Incidence of new healthcare visits for further stone management

  4. Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire

    Time frame: Day of procedure to 14 months posts procedure

    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/.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbrina Dunmire, MS

CONTACT

[email protected]

Michael Bailey, PhD

CONTACT

[email protected]

206-619-2035

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study title

Ultrasound Technology to Fragment and Reposition Urinary Stones

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 15, 2021
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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