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NCT Number: NCT03873259

Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

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.

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Key information

Conditions

Renal Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Calculi Ureteral Diseases Ureterolithiasis 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

IU Health North Hospital, Carmel, Indiana, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals presenting with at least one kidney stone apparent on CT
  • Individuals scheduled for clinical stone removal via ureteroscopy (URS)

Exclusion criteria

  • 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

Treatment and study plan

Burst Wave Lithotripsy

Device

Fragment upper urinary tract stones

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Safety - Adverse Event Assessment

    Time frame: out to 120 days post-procedure

    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

  2. Effectiveness - Time to Full Comminution

    Time frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.

    projected time to full comminution defined as the time at which no fragments would be ≤ 2 mm

Study contacts

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

Barbrina Dunmire

CONTACT

[email protected]

206-769-5910

Michael R Bailey, PhD, MS

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)

Registry information

Official study title

Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Mar 13, 2019
Registry last updated
Jul 21, 2026

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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