SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) (SOUND)

• ClinicalTrials.gov Identifier: NCT05701098
• Recruitment Status: Recruiting
• First Posted: January 27, 2023
• Last Update Posted: February 28, 2024
• Sponsor: SonoMotion
• Information provided by (Responsible Party): SonoMotion

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Kidney Stone; Urolithiasis; Nephrolithiasis; Renal Calculi; Kidney Calculi; Nephrolith; Urinary Calculi	Device: Break Wave extracorporeal lithotripsy	Not Applicable

Detailed Description:

This is a prospective, open-label, multi-center, single-arm (non-randomized) study to demonstrate the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave™ technology. Up to 116 patients will be screened to participate. Depending on the institution, the procedure may be performed in an outpatient hospital surgical environment, or in a non-surgical environment such as a clinic or office procedure room. Subjects will have a target stone diagnosed to be >4millimeter (mm) to 10 mm in size.

Safety will be measured by the adverse event occurrence, unplanned emergency department or clinic visits, and the need for further intervention. Effectiveness will be determined by the size of fragments identified at the 10 week follow-up imaging.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 116 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pivotal Study of the SonoMotion Break Wave™ (Trade Mark) System for the Comminution of Urinary Tract Stones
• Actual Study Start Date: October 9, 2023
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: January 2025

Arms and Interventions

Arm

Intervention/treatment

Experimental: Break Wave™ Procedure; The subject will undergo the Break Wave procedure.

Device: Break Wave extracorporeal lithotripsy; 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.

Outcome Measures

Primary Outcome Measures :

1. Primary Effectiveness Endpoint [ Time Frame: 10 +/- 2 weeks post final Break Wave procedure ]
   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).
2. Primary Safety Endpoint [ Time Frame: During procedure and through 90 days post-procedure ]
   Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia

Secondary Outcome Measures :

1. Secondary safety endpoint [ Time Frame: During procedure and through 90 days post-procedure ]
   Occurrence of all device and procedure related adverse events (AEs), including serious adverse events (SAEs), and Unanticipated Adverse Device Effects (UADEs)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Subject has an acute untreated urinary tract infection or urosepsis.
2. Subject has an uncorrected bleeding disorder or coagulation abnormality.
3. Subject is confirmed to be or suspected to be pregnant.
4. Subject has a urinary tract obstruction distal to the stone.
5. Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
6. Subject has stones that are not echogenically visible with ultrasound.
7. Subject belongs to a vulnerable group (prisoner, etc.).
8. Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging.
9. Subject is under 18 years of age.
10. Subject's anatomy limits ability to focus on or deliver Break Wave to the target stone (e.g. viable acoustic window).
11. Subject has a calcified abdominal aortic aneurysm or calcified renal artery aneurysms.
12. Subject has a solitary kidney.
13. 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.
14. Subject is unable to read or comprehend the consent form.

Contacts and Locations

Contacts

Contact: Emily Hergenreter; 9255949600; emily.hergenreter@sonomotion.com

Locations

United States, California

University of California- San Diego; Recruiting

San Diego, California, United States, 92037

Contact: Jamie Finegan jlfinegan@health.ucsd.edu

Principal Investigator: Roger Sur, MD

University of California - San Francisco; Recruiting

San Francisco, California, United States, 94143

Contact: Michelle Li Michelle.Li2@ucsf.edu

Contact: Victoria Hogue victoria.hogue@ucsf.edu

Principal Investigator: Justin Ahn, MD

Sub-Investigator: Ralph Wang, MD

Kaiser Permanente; Recruiting

Santa Clara, California, United States, 95051

Contact: Yasha Rezaeihaghighi, RN yasha.reza@kp.org

Principal Investigator: Helena Chang, MD

Sub-Investigator: Leo Chen, MD

United States, Illinois

Northwestern Medicine; Recruiting

Chicago, Illinois, United States, 60611

Contact: Alyssa McDonald alyssa.mcdonald@northwestern.edu

Principal Investigator: Amy E. Krambeck, MD

Sub-Investigator: Madhvi Deol, MD

Sub-Investigator: Nicholas Dean, MD

Sub-Investigator: Amanda Vo, MD

United States, Pennsylvania

Lehigh Valley Health Network; Recruiting

Allentown, Pennsylvania, United States, 18103

Contact: Samuel Rivera samuel.rivera@lvhn.org

Principal Investigator: James R. Johannes, MD

Sub-Investigator: Errin J. Hoffman, MD

United States, Tennessee

Vanderbilt University; Not yet recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator: Nicholas Kavoussi, MD

United States, Washington

University of Washington; Recruiting

Seattle, Washington, United States, 98195

Contact: Barbara H Burke burkeb3@uw.edu

Principal Investigator: Jonathan D. Harper, MD

Sub-Investigator: M. Kennedy Hall, MD

Sub-Investigator: Mathew D. Sorensen, MD

Canada, Alberta

University of Alberta; Recruiting

Edmonton, Alberta, Canada, T6G 1Z1

Contact: Ijeoma Ogbuehi, PhD ogbuehi@ualberta.ca

Principal Investigator: Shubha K. De, MD

Sub-Investigator: Rahim Samji, MD

Sub-Investigator: Tim A Wollin, MD

Sub-Investigator: Trevor Schuler, MD

Sub-Investigator: Richard Bochinski, MD

Canada, British Columbia

University of British Columbia; Recruiting

Vancouver, British Columbia, Canada

Contact: Victor Wong victor.kf.wong@ubc.ca

Principal Investigator: Ben Chew, MD

Sub-Investigator: Connor Forbes, MD

Sub-Investigator: Ryan Patterson, MD

Canada, Ontario

St. Michael's Hospital, University of Toronto; Not yet recruiting

Toronto, Ontario, Canada, M5C 2T2

Contact: Daniela Ghiculete, MD MSc daniela.ghiculete@unityhealth.to

Principal Investigator: Kenneth Pace, MD Msc FRCSC

Sponsors and Collaborators

SonoMotion

More Information

• Responsible Party: SonoMotion
• ClinicalTrials.gov Identifier: NCT05701098
• Other Study ID Numbers: CP0002
• First Posted: January 27, 2023
• Last Update Posted: February 28, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by SonoMotion:

Kidney Stone; Urolithiasis; Nephrolithiasis; Renal Calculi; Kidney Calculi; Nephrolith; Urinary Calculi; Ultrasound therapy; Non-invasive; Extracorporeal

Additional relevant MeSH terms:

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