NCT05701098

Brief Summary

The goal of this clinical trial is to test the Break Wave™ system in patients with upper urinary tract stones. The main question it aims to answer is whether the device is safe and effective in fragmenting (breaking) stones. Participants will a) undergo the Break Wave™ procedure, b) have a telehealth visit at 2 weeks, and c) return for an imaging study at approximately 10 weeks post-procedure.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

January 11, 2023

Last Update Submit

April 28, 2026

Conditions

Kidney StoneUrolithiasisNephrolithiasisRenal CalculiKidney CalculiNephrolithUrinary Calculi

Keywords

Kidney StoneUrolithiasisNephrolithiasisRenal CalculiKidney CalculiNephrolithUrinary CalculiUltrasound therapyNon-invasiveExtracorporeal

Outcome Measures

Primary Outcomes (2)

  • Primary Effectiveness Endpoint

    Proportion of subjects with a radiographic assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (≤ 4 mm).

    10 +/- 2 weeks post final Break Wave procedure

  • Primary Safety Endpoint

    Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia

    During procedure and through 90 days post-procedure

Secondary Outcomes (1)

  • Secondary safety endpoint

    During procedure and through 90 days post-procedure

Study Arms (1)

Break Wave™ Procedure

EXPERIMENTAL

The subject will undergo the Break Wave procedure.

Device: Break Wave extracorporeal lithotripsy

Interventions

Break Wave extracorporeal lithotripsyDEVICE

The Break Wave device will be used to exert a low amplitude burst of ultrasound waves focused at the kidney stone. The primary components of the device include an ultrasound imaging system and a therapy probe driven by a high voltage generator. The probe will be placed on the patient's skin, the stone located via diagnostic ultrasound and up to 30 minutes of therapy will be delivered to the stone. The therapy probe accommodates coaxial alignment of an ultrasound imaging probe for treatment guidance.

Break Wave™ Procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects presenting with at least one stone apparent on radiographic imaging.
  • Target stone must be within the upper urinary tract.
  • Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines.
  • Target stone size is \> 4 mm and ≤ 10 mm.
  • Subject is willing and able to provide informed consent and comply with the study protocol required follow up visits.
  • Target stone can be individually visualized from other stones.

You may not qualify if:

  • Subject has an acute untreated urinary tract infection or urosepsis.
  • Subject has an uncorrected bleeding disorder or coagulation abnormality.
  • Subject is confirmed to be or suspected to be pregnant.
  • Subject has a urinary tract obstruction distal to the stone.
  • Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
  • Subject has stones that are not echogenically visible with ultrasound.
  • Subject belongs to a vulnerable group (prisoner, etc.).
  • Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging.
  • Subject is under 18 years of age.
  • Subject's anatomy limits ability to focus on or deliver Break Wave to the target stone (e.g. viable acoustic window).
  • Subject has a calcified abdominal aortic aneurysm or calcified renal artery aneurysms.
  • Subject has a solitary kidney.
  • Subject has a comorbidity risk(s) which, at the discretion of the physician, would make the subject a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
  • Subject is unable to read or comprehend the consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of California- San Diego

San Diego, California, 92037, United States

Location

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Kaiser Permanente

Santa Clara, California, 95051, United States

Location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Alberta

Edmonton, Alberta, T6G 1Z1, Canada

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

St. Michael's Hospital, University of Toronto

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (1)

  • Chew BH, Harper JD, Sur RL, Chi T, De S, Buckley AR, Paterson RF, Wong VKF, Forbes CM, Hall MK, Kessler R, Bechis SK, Woo JR, Wang RC, Bayne DB, Bochinski D, Schuler TD, Wollin TA, Samji R, Sorensen MD. Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial. J Urol. 2024 Oct;212(4):580-589. doi: 10.1097/JU.0000000000004091. Epub 2024 Sep 10.

    PMID: 39254129DERIVED

MeSH Terms

Conditions

Kidney CalculiUrolithiasisNephrolithiasisUrinary Calculi

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 27, 2023

Study Start

October 9, 2023

Primary Completion

June 18, 2025

Study Completion

July 31, 2025

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(7)CA(3)