<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/NCT02214836</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00003444</org_study_id>
    <secondary_id>P01DK043881</secondary_id>
    <nct_id>NCT02214836</nct_id>
  </id_info>
  <brief_title>Ultrasound Imaging of Kidney Stones and Lithotripsy</brief_title>
  <official_title>Ultrasound Imaging of Kidney Stones and Lithotripsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to determine whether new software processing of ultrasound&#xD;
      images can improve detection and size determination of kidney stones.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of our research is to improve the ability to see kidney stones with ultrasound&#xD;
      imaging. Specifically, we are testing how well new stone specific processing can find stones&#xD;
      and show their size. Ultimately, better imaging can improve the care of future patients.&#xD;
&#xD;
      Patients with kidney stones or undergoing surgery for kidney stones will be recruited and&#xD;
      consented.&#xD;
&#xD;
      We will image the kidney and ureter stones of consented subjects. We will place a water-based&#xD;
      gel and ultrasound probe against the subject's skin on the back, sides, and abdomen. We will&#xD;
      save the images and the raw electrical signals received from the probe and used to make the&#xD;
      images. The images will be used to estimate the location and size of kidney stones in the&#xD;
      kidney or ureter. The size and location will also be determined from x-ray and ultrasound&#xD;
      images and reports already in the subject's medical record. And for recruited subjects who&#xD;
      are already undergoing surgery in an existing clinical not research procedure, the surgeon&#xD;
      will also measure location and size of stones seen in surgery. All these measurements of size&#xD;
      and location of kidney stones will be compared to test the accuracy of the new ultrasound&#xD;
      image processing.&#xD;
&#xD;
      After the examination, we will not ask anything more of subjects, but we will collect some&#xD;
      information from their existing medical records. This information includes existing images of&#xD;
      your stones, size of stones, location of stones, number of stones, type of stones, and&#xD;
      treatment records. We will also record your weight, height, race, and ethnicity. Not all this&#xD;
      information may be available. We will use what information is available. This additional&#xD;
      information is used to test how well our ultrasound exam did. It also shows if we do better&#xD;
      with certain groups of patients, for example, for certain stone types or body sizes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 1, 2023</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2024</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and location of stones identified on research ultrasound vs. clinically. The outcome measured will be the accuracy new ultrasound images versus existing clinical data.</measure>
    <time_frame>Research data are collected on Day 1 (the day of the research imaging procedure). Clinical data are also available on Day 1. Clinical data will be downloaded by Day 7, and comparison will be made by Day 14.</time_frame>
    <description>Number and location of stones will be measured in one research procedure at the time of the procedure. These will be compared to measurements of number and location made in the clinical surgery procedure and to measurements from clinical imaging.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Size of stones determined with research ultrasound vs. clinically. The outcome measured will be the accuracy new ultrasound images versus existing clinical data.</measure>
    <time_frame>Research data are collected on Day 1 (the day of the research imaging procedure). Clinical data are also available on Day 1. Clinical data will be downloaded by Day 7, and comparison will be made by Day 14.</time_frame>
    <description>The size of stones will be measured in one research procedure at the time of the procedure. These will be compared to measurements of number and location made in the clinical surgery procedure and to measurements from clinical imaging.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">370</enrollment>
  <condition>Kidney Stones</condition>
  <condition>Nephrolithiasis</condition>
  <condition>Urolithiasis</condition>
  <condition>Ureter Stones</condition>
  <arm_group>
    <arm_group_label>Kidney stones</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: Verasonics Data Acquisition System (VDAS)&#xD;
Other Names:&#xD;
Verasonics Data Acquisition System (VDAS) Verasonics Ultrasound Engine Subjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been modified.&#xD;
Subjects in this arm will be imaged by ultrasound by the VDAS. Stone location and size will be determined and compared to clinical determination of stone location and size.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Verasonics Data Acquisition System (VDAS)</intervention_name>
    <description>Subjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been modified. Stone location and size will be determined and compared to clinical determination of stone location and size.</description>
    <arm_group_label>Kidney stones</arm_group_label>
    <other_name>Verasonics Ultrasound Engine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with kidney stones that are visible on x-ray (i.e., calcium stones)&#xD;
&#xD;
          -  Current CT scan within the 90-day pre-operative period&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Age 21 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Age less than 21 years&#xD;
&#xD;
          -  Stones not visible on x-ray&#xD;
&#xD;
          -  Patients with systemic disease or renal anatomical disorders (RTA, primary&#xD;
             hyperparathyroidism, sarcoidosis, enteric hyperoxaluria, medullary sponge kidney)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Bailey</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Bailey, PhD</last_name>
    <phone>206-685-8618</phone>
    <email>bailey@apl.washington.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Barbrina Dunmire</last_name>
    <phone>206-685-6953</phone>
    <email>mrbean@uw.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Washington, Department of Urology</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Jonathan Harper, MD</last_name>
      <phone>206-543-3640</phone>
      <email>jdharper@uw.edu</email>
    </contact>
    <investigator>
      <last_name>Jonathan Harper, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Michael Bailey</investigator_full_name>
    <investigator_title>Research Engineer</investigator_title>
  </responsible_party>
  <keyword>kidney stones</keyword>
  <keyword>ultrasound imaging</keyword>
  <keyword>ureter stones</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>Urolithiasis</mesh_term>
    <mesh_term>Ureteral Calculi</mesh_term>
    <mesh_term>Ureterolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <!-- 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/NCT02214836
org study id: STUDY00003444
secondary id: P01DK043881
nct id: NCT02214836
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to determine whether new software processing of ultrasound
      images can improve detection and size determination of kidney stones.
The purpose of our research is to improve the ability to see kidney stones with ultrasound
      imaging. Specifically, we are testing how well new stone specific processing can find stones
      and show their size. Ultimately, better imaging can improve the care of future patients.

      Patients with kidney stones or undergoing surgery for kidney stones will be recruited and
      consented.

      We will image the kidney and ureter stones of consented subjects. We will place a water-based
      gel and ultrasound probe against the subject's skin on the back, sides, and abdomen. We will
      save the images and the raw electrical signals received from the probe and used to make the
      images. The images will be used to estimate the location and size of kidney stones in the
      kidney or ureter. The size and location will also be determined from x-ray and ultrasound
      images and reports already in the subject's medical record. And for recruited subjects who
      are already undergoing surgery in an existing clinical not research procedure, the surgeon
      will also measure location and size of stones seen in surgery. All these measurements of size
      and location of kidney stones will be compared to test the accuracy of the new ultrasound
      image processing.

      After the examination, we will not ask anything more of subjects, but we will collect some
      information from their existing medical records. This information includes existing images of
      your stones, size of stones, location of stones, number of stones, type of stones, and
      treatment records. We will also record your weight, height, race, and ethnicity. Not all this
      information may be available. We will use what information is available. This additional
      information is used to test how well our ultrasound exam did. It also shows if we do better
      with certain groups of patients, for example, for certain stone types or body sizes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number and location of stones identified on research ultrasound vs. clinically. The outcome measured will be the accuracy new ultrasound images versus existing clinical data.
time frame: Research data are collected on Day 1 (the day of the research imaging procedure). Clinical data are also available on Day 1. Clinical data will be downloaded by Day 7, and comparison will be made by Day 14.
description: Number and location of stones will be measured in one research procedure at the time of the procedure. These will be compared to measurements of number and location made in the clinical surgery procedure and to measurements from clinical imaging.
measure: Size of stones determined with research ultrasound vs. clinically. The outcome measured will be the accuracy new ultrasound images versus existing clinical data.
time frame: Research data are collected on Day 1 (the day of the research imaging procedure). Clinical data are also available on Day 1. Clinical data will be downloaded by Day 7, and comparison will be made by Day 14.
description: The size of stones will be measured in one research procedure at the time of the procedure. These will be compared to measurements of number and location made in the clinical surgery procedure and to measurements from clinical imaging.
arm group label: Kidney stones
arm group type: Experimental
description: Device: Verasonics Data Acquisition System (VDAS)
Other Names:
Verasonics Data Acquisition System (VDAS) Verasonics Ultrasound Engine Subjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been modified.
Subjects in this arm will be imaged by ultrasound by the VDAS. Stone location and size will be determined and compared to clinical determination of stone location and size.
intervention type: Device
intervention name: Verasonics Data Acquisition System (VDAS)
description: Subjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been modified. Stone location and size will be determined and compared to clinical determination of stone location and size.
arm group label: Kidney stones
other name: Verasonics Ultrasound Engine
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Bailey
role: Principal Investigator
affiliation: University of Washington
last name: Michael Bailey, PhD
phone: 206-685-8618
email: bailey@apl.washington.edu
last name: Barbrina Dunmire
phone: 206-685-6953
email: mrbean@uw.edu
facility: 
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Michael Bailey
investigator title: Research Engineer
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Urolithiasis
mesh term: Ureteral Calculi
mesh term: Ureterolithiasis
mesh term: Calculi