Back to resultsSOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) (SOUND)
Primary Purpose
Kidney Stone, Urolithiasis, Nephrolithiasis
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Break Wave extracorporeal lithotripsy
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone focused on measuring Kidney Stone, Urolithiasis, Nephrolithiasis, Renal Calculi, Kidney Calculi, Nephrolith, Urinary Calculi, Ultrasound therapy, Non-invasive, Extracorporeal
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- University of California- San DiegoRecruiting
- University of California - San FranciscoRecruiting
- Kaiser Permanente
- Northwestern MedicineRecruiting
- Lehigh Valley Health NetworkRecruiting
- Vanderbilt University
- University of Washington
- University of Alberta
- University of British ColumbiaRecruiting
- St. Michael's Hospital, University of Toronto
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Break Wave™ Procedure
Arm Description
The subject will undergo the Break Wave procedure.
Outcomes
Primary Outcome Measures
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).
Primary Safety Endpoint
Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia
Secondary Outcome Measures
Secondary safety endpoint
Occurrence of all device and procedure related adverse events (AEs), including serious adverse events (SAEs), and Unanticipated Adverse Device Effects (UADEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05701098
Brief Title
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
Acronym
SOUND
Official Title
Pivotal Study of the SonoMotion Break Wave™ (Trade Mark) System for the Comminution of Urinary Tract Stones
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SonoMotion
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Urolithiasis, Nephrolithiasis, Renal Calculi, Kidney Calculi, Nephrolith, Urinary Calculi
Keywords
Kidney Stone, Urolithiasis, Nephrolithiasis, Renal Calculi, Kidney Calculi, Nephrolith, Urinary Calculi, Ultrasound therapy, Non-invasive, Extracorporeal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Break Wave™ Procedure
Arm Type
Experimental
Arm Description
The subject will undergo the Break Wave procedure.
Intervention Type
Device
Intervention Name(s)
Break Wave extracorporeal lithotripsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
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).
Time Frame
10 +/- 2 weeks post final Break Wave procedure
Title
Primary Safety Endpoint
Description
Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia
Time Frame
During procedure and through 90 days post-procedure
Secondary Outcome Measure Information:
Title
Secondary safety endpoint
Description
Occurrence of all device and procedure related adverse events (AEs), including serious adverse events (SAEs), and Unanticipated Adverse Device Effects (UADEs)
Time Frame
During procedure and through 90 days post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Hergenreter
Phone
9255949600
Email
emily.hergenreter@sonomotion.com
Facility Information:
Facility Name
University of California- San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Finegan
Email
jlfinegan@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Roger Sur, MD
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Li
Email
Michelle.Li2@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Victoria Hogue
Email
victoria.hogue@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Justin Ahn, MD
First Name & Middle Initial & Last Name & Degree
Ralph Wang, MD
Facility Name
Kaiser Permanente
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasha Rezaeihaghighi, RN
Email
yasha.reza@kp.org
First Name & Middle Initial & Last Name & Degree
Helena Chang, MD
First Name & Middle Initial & Last Name & Degree
Leo Chen, MD
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa McDonald
Email
alyssa.mcdonald@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Amy E. Krambeck, MD
First Name & Middle Initial & Last Name & Degree
Madhvi Deol, MD
First Name & Middle Initial & Last Name & Degree
Nicholas Dean, MD
First Name & Middle Initial & Last Name & Degree
Amanda Vo, MD
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Rivera
Email
samuel.rivera@lvhn.org
First Name & Middle Initial & Last Name & Degree
James R. Johannes, MD
First Name & Middle Initial & Last Name & Degree
Errin J. Hoffman, MD
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Kavoussi, MD
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara H Burke
Email
burkeb3@uw.edu
First Name & Middle Initial & Last Name & Degree
Jonathan D. Harper, MD
First Name & Middle Initial & Last Name & Degree
M. Kennedy Hall, MD
First Name & Middle Initial & Last Name & Degree
Mathew D. Sorensen, MD
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ijeoma Ogbuehi, PhD
Email
ogbuehi@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Shubha K. De, MD
First Name & Middle Initial & Last Name & Degree
Rahim Samji, MD
First Name & Middle Initial & Last Name & Degree
Tim A Wollin, MD
First Name & Middle Initial & Last Name & Degree
Trevor Schuler, MD
First Name & Middle Initial & Last Name & Degree
Richard Bochinski, MD
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Wong
Email
victor.kf.wong@ubc.ca
First Name & Middle Initial & Last Name & Degree
Ben Chew, MD
First Name & Middle Initial & Last Name & Degree
Connor Forbes, MD
First Name & Middle Initial & Last Name & Degree
Ryan Patterson, MD
Facility Name
St. Michael's Hospital, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Ghiculete, MD MSc
Email
daniela.ghiculete@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Kenneth Pace, MD Msc FRCSC
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
We'll reach out to this number within 24 hrs