<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03811171</url>
  </required_header>
  <id_info>
    <org_study_id>CLP-0001</org_study_id>
    <nct_id>NCT03811171</nct_id>
  </id_info>
  <brief_title>Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study</brief_title>
  <official_title>A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SonoMotion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SonoMotion</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess&#xD;
      the safety and effectiveness of breaking stones in the upper urinary tract using the&#xD;
      SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be&#xD;
      performed in a hospital surgical environment as an outpatient (without being admitted) or in&#xD;
      a non-surgical environment such as a clinic or office procedure room. The procedure will be&#xD;
      performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia&#xD;
      (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm&#xD;
      everywhere else.&#xD;
&#xD;
      Safety will be measured by the self-reported occurrences of adverse events, unplanned&#xD;
      emergency department or clinic visits, and the need for further intervention. Fragmentation&#xD;
      will be measured by self-reported stone passage and a comparison of computed tomography (CT)&#xD;
      images before and after the procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 20, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Effectiveness Outcome - Stone Fragmentation</measure>
    <time_frame>12 weeks post-treatment</time_frame>
    <description>Stone fragmentation as determined by stone passage or imaging confirmation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia</measure>
    <time_frame>12 weeks post-treatment</time_frame>
    <description>The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary effectiveness outcome - Stone Free Status</measure>
    <time_frame>12 weeks post-treatment</time_frame>
    <description>Radiographic evidence (CT imaging) of stone free status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary effectiveness outcome - Residual fragment size</measure>
    <time_frame>12 weeks post-treatment</time_frame>
    <description>Presence of only stone fragments small enough to pass (less than or equal to 4 mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary safety outcome - Adverse events</measure>
    <time_frame>12 weeks post-treatment</time_frame>
    <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)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Renal Calculi</condition>
  <condition>Urinary Calculi</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The arm receives the investigational Break Wave procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Break Wave extracorporeal lithotripsy</intervention_name>
    <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.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals presenting with at least one kidney stone apparent on CT.&#xD;
&#xD;
          -  Stones must be within the upper urinary tract.&#xD;
&#xD;
          -  Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016&#xD;
             guidelines.8&#xD;
&#xD;
          -  Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10&#xD;
             mm for lower pole stones and ≤ 20 mm for non-lower pole stones).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute untreated urinary tract infection or urosepsis.&#xD;
&#xD;
          -  Uncorrected bleeding disorders or coagulopathies.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Uncorrected obstruction distal to the stone.&#xD;
&#xD;
          -  Patients receiving anticoagulants and who are unable or not willing to cease the&#xD;
             medication for the Break Wave procedure.&#xD;
&#xD;
          -  Stones that are not echogenically visible or cannot be positioned within the Break&#xD;
             Wave therapy focus.&#xD;
&#xD;
          -  Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner,&#xD;
             etc.).&#xD;
&#xD;
          -  Patients unwilling to comply with the follow-up protocol, including post-procedure CT.&#xD;
&#xD;
          -  Individuals under 18 years of age.&#xD;
&#xD;
          -  Anatomic presentations preventing adequate positioning or delivery of the Break Wave&#xD;
             pulse.&#xD;
&#xD;
          -  Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.&#xD;
&#xD;
          -  Solitary kidney&#xD;
&#xD;
          -  Comorbidity risks which, in at the discretion of the physician, would make the patient&#xD;
             a poor candidate for the Break Wave procedure, such as anatomical anomalies that may&#xD;
             not be conducive to adequate stone fragment passage.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Oren Levy, PhD</last_name>
    <phone>4156722631</phone>
    <email>oren.levy@sonomotion.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California San Diego Health</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roger Sur</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Chi, MD</last_name>
      <phone>415-353-2200</phone>
      <email>tom.chi@ucsf.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ralph Wang, MD</last_name>
      <phone>415-353-1634</phone>
      <email>ralph.wang@ucsf.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barb Burke</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Alberta, Division of Urology</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G1Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuba De, MD</last_name>
      <phone>780-407-5800</phone>
      <email>shubha1@ualberta.ca</email>
    </contact>
    <contact_backup>
      <last_name>Breanne Stewart, RN</last_name>
      <phone>780-974-8606</phone>
      <email>breanne1@ualberta.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital Stone Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>BC V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ben Chew</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Michael's Unity Health Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2T2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kenneth Pace, MD</last_name>
      <phone>416-867-3695</phone>
      <email>Kenneth.Pace@unityhealth.to</email>
    </contact>
    <contact_backup>
      <last_name>Daniela Ghiculete, MSc</last_name>
      <phone>416-864-6060</phone>
      <email>Daniela.Ghiculete@unityhealth.to</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sonomotion.com</url>
    <description>Sponsor Website</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>25111910</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>32237849</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>32611160</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>35311351</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stone</keyword>
  <keyword>Lithotripsy</keyword>
  <keyword>Calculi</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Urinary Calculi</mesh_term>
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03811171
org study id: CLP-0001
nct id: NCT03811171
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Effectiveness Outcome - Stone Fragmentation
time frame: 12 weeks post-treatment
description: Stone fragmentation as determined by stone passage or imaging confirmation.
measure: Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
time frame: 12 weeks post-treatment
description: The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.
measure: Secondary effectiveness outcome - Stone Free Status
time frame: 12 weeks post-treatment
description: Radiographic evidence (CT imaging) of stone free status.
measure: Secondary effectiveness outcome - Residual fragment size
time frame: 12 weeks post-treatment
description: Presence of only stone fragments small enough to pass (less than or equal to 4 mm).
measure: Secondary safety outcome - Adverse events
time frame: 12 weeks post-treatment
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)
arm group label: Treatment
arm group type: Experimental
description: The arm receives the investigational Break Wave procedure.
intervention type: Device
intervention name: Break Wave extracorporeal lithotripsy
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.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oren Levy, PhD
phone: 4156722631
email: oren.levy@sonomotion.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
country: Canada
country: United States
url: http://www.sonomotion.com
description: Sponsor Website
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.
PMID: 25111910
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.
PMID: 32237849
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.
PMID: 32611160
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.
PMID: 35311351
responsible party type: Sponsor
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Urinary Calculi
mesh term: Urolithiasis
mesh term: Calculi
sharing ipd: No