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Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study

Primary Purpose

Renal Calculi, Urinary Calculi

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Break Wave extracorporeal lithotripsy
Sponsored by
SonoMotion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Calculi focused on measuring Stone, Lithotripsy, Calculi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals presenting with at least one kidney stone apparent on CT.
  • Stones must be within the upper urinary tract.
  • Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
  • Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).

Exclusion Criteria:

  • Acute untreated urinary tract infection or urosepsis.
  • Uncorrected bleeding disorders or coagulopathies.
  • Pregnancy.
  • Uncorrected obstruction distal to the stone.
  • Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
  • Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
  • Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.).
  • Patients unwilling to comply with the follow-up protocol, including post-procedure CT.
  • Individuals under 18 years of age.
  • Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse.
  • Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.
  • Solitary kidney
  • Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.

Sites / Locations

  • University of California San Diego HealthRecruiting
  • University of California, San FranciscoRecruiting
  • University of Washington Medical CenterRecruiting
  • University of Alberta, Division of UrologyRecruiting
  • Vancouver General Hospital Stone CentreRecruiting
  • St. Michael's Unity Health Toronto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

The arm receives the investigational Break Wave procedure.

Outcomes

Primary Outcome Measures

Primary Effectiveness Outcome - Stone Fragmentation
Stone fragmentation as determined by stone passage or imaging confirmation.
Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.

Secondary Outcome Measures

Secondary effectiveness outcome - Stone Free Status
Radiographic evidence (CT imaging) of stone free status.
Secondary effectiveness outcome - Residual fragment size
Presence of only stone fragments small enough to pass (less than or equal to 4 mm).
Secondary safety outcome - Adverse events
documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events associated with shock wave lithotripsy (SWL)

Full Information

First Posted
January 17, 2019
Last Updated
February 22, 2023
Sponsor
SonoMotion
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1. Study Identification

Unique Protocol Identification Number
NCT03811171
Brief Title
Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
Official Title
A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else. Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculi, Urinary Calculi
Keywords
Stone, Lithotripsy, Calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
The arm receives the investigational 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 85 mm aperture diameter therapy probe driven by a high voltage generator. The therapy probe has a cavity in the middle to accommodate coaxial alignment of an ultrasound imaging probe for treatment guidance.
Primary Outcome Measure Information:
Title
Primary Effectiveness Outcome - Stone Fragmentation
Description
Stone fragmentation as determined by stone passage or imaging confirmation.
Time Frame
12 weeks post-treatment
Title
Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
Description
The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.
Time Frame
12 weeks post-treatment
Secondary Outcome Measure Information:
Title
Secondary effectiveness outcome - Stone Free Status
Description
Radiographic evidence (CT imaging) of stone free status.
Time Frame
12 weeks post-treatment
Title
Secondary effectiveness outcome - Residual fragment size
Description
Presence of only stone fragments small enough to pass (less than or equal to 4 mm).
Time Frame
12 weeks post-treatment
Title
Secondary safety outcome - Adverse events
Description
documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events associated with shock wave lithotripsy (SWL)
Time Frame
12 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals presenting with at least one kidney stone apparent on CT. Stones must be within the upper urinary tract. Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8 Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones). Exclusion Criteria: Acute untreated urinary tract infection or urosepsis. Uncorrected bleeding disorders or coagulopathies. Pregnancy. Uncorrected obstruction distal to the stone. Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure. Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus. Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.). Patients unwilling to comply with the follow-up protocol, including post-procedure CT. Individuals under 18 years of age. Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse. Calcified abdominal aortic aneurysms or calcified renal artery aneurysms. Solitary kidney Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oren Levy, PhD
Phone
4156722631
Email
oren.levy@sonomotion.com
Facility Information:
Facility Name
University of California San Diego Health
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Sur
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
Thomas Chi, MD
Phone
415-353-2200
Email
tom.chi@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Ralph Wang, MD
Phone
415-353-1634
Email
ralph.wang@ucsf.edu
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barb Burke
Facility Name
University of Alberta, Division of Urology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuba De, MD
Phone
780-407-5800
Email
shubha1@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Breanne Stewart, RN
Phone
780-974-8606
Email
breanne1@ualberta.ca
Facility Name
Vancouver General Hospital Stone Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
BC V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Chew
Facility Name
St. Michael's Unity Health 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
Kenneth Pace, MD
Phone
416-867-3695
Email
Kenneth.Pace@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Daniela Ghiculete, MSc
Phone
416-864-6060
Email
Daniela.Ghiculete@unityhealth.to

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25111910
Citation
Maxwell AD, Cunitz BW, Kreider W, Sapozhnikov OA, Hsi RS, Harper JD, Bailey MR, Sorensen MD. Fragmentation of urinary calculi in vitro by burst wave lithotripsy. J Urol. 2015 Jan;193(1):338-44. doi: 10.1016/j.juro.2014.08.009. Epub 2014 Aug 9.
Results Reference
background
PubMed Identifier
32237849
Citation
Maxwell AD, MacConaghy B, Bailey MR, Sapozhnikov OA. An investigation of elastic waves producing stone fracture in burst wave lithotripsy. J Acoust Soc Am. 2020 Mar;147(3):1607. doi: 10.1121/10.0000847.
Results Reference
background
PubMed Identifier
32611160
Citation
Sapozhnikov OA, Maxwell AD, Bailey MR. Modeling of photoelastic imaging of mechanical stresses in transparent solids mimicking kidney stones. J Acoust Soc Am. 2020 Jun;147(6):3819. doi: 10.1121/10.0001386.
Results Reference
background
PubMed Identifier
35311351
Citation
Harper JD, Lingeman JE, Sweet RM, Metzler IS, Sunaryo PL, Williams JC Jr, Maxwell AD, Thiel J, Cunitz BW, Dunmire B, Bailey MR, Sorensen MD. Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans. J Urol. 2022 May;207(5):1067-1076. doi: 10.1097/JU.0000000000002446. Epub 2022 Mar 21.
Results Reference
background
Links:
URL
http://www.sonomotion.com
Description
Sponsor Website

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Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study

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