<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/NCT04423458</url>
  </required_header>
  <id_info>
    <org_study_id>848 -20HH6053</org_study_id>
    <nct_id>NCT04423458</nct_id>
  </id_info>
  <brief_title>Evaluation of Advanced US Tools in Assessing Allograft Complications</brief_title>
  <official_title>The Evaluation of Advanced Ultrasonography Applications in the Assessment of Transplanted Kidney Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the role of advanced US technology in assessing renal transplants as&#xD;
      screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound&#xD;
      conventional metheds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will focus on monitoring renal after transplantation using all US advanced&#xD;
      technology.&#xD;
&#xD;
      Aim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the&#xD;
      gold standard.&#xD;
&#xD;
      Aim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness.&#xD;
&#xD;
      Aim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in&#xD;
      three groups.&#xD;
&#xD;
      Duration: 18 Months; participants will have a patient information sheet; once they are happy&#xD;
      to participate, consent will be obtained.&#xD;
&#xD;
      Study data will be entered into a database encrypted and stored in the department. Only the&#xD;
      study principal investigator (PI) will know the study database password.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2022</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Peak systolic velocity (cm/s).</measure>
    <time_frame>12 weeks</time_frame>
    <description>Pean of the blood flow velocities in the artery/ vein peak systolic velocity ≥200 cm/s velocity difference between pre- and post-stenotic segments of 2:1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak systolic velocity ratio (PSVR).</measure>
    <time_frame>12 weeks</time_frame>
    <description>High velocity flow at the stenosis site divided by a reference velocity (normal before stenosis)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resistive Index (RI).</measure>
    <time_frame>12 weeks</time_frame>
    <description>An RI less than 0.7 to 0.8 is considered normal, more than that it is indicator of transplant dysfunction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Volumetric stenosis.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3D GSM.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Renal Failure</condition>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Failure,Kidney</condition>
  <condition>Renal Artery Stenosis</condition>
  <condition>Fibrosis</condition>
  <condition>Complications</condition>
  <arm_group>
    <arm_group_label>Transplanted kidney</arm_group_label>
    <description>No intervention is required. Routine Doppler assessment + 3D scan + Shear wave elastography + MicrFlow Imaging will be immediately recorded afterwards</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D imaging</intervention_name>
    <description>The study will focus on the accuracy of ultrasound technology in assessing renal transplants.&#xD;
The entire assessment should not take more than 25 minutes.</description>
    <arm_group_label>Transplanted kidney</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients having /had kindey transplant&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
          -  Patients ≥ 18 years.&#xD;
&#xD;
          -  Tx patients.&#xD;
&#xD;
          -  Gender.&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  Prisoners.&#xD;
&#xD;
          -  Patients &lt; 18 years.&#xD;
&#xD;
          -  Pregnant women&#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_official>
    <last_name>Mohammed Aslam, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Academic Supervisor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Imperial College London</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>3D Ultrasound</keyword>
  <keyword>US elastography</keyword>
  <keyword>US MFI</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>MRI</keyword>
  <keyword>CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Artery Obstruction</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/NCT04423458
org study id: 848 -20HH6053
nct id: NCT04423458
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the role of advanced US technology in assessing renal transplants as
      screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound
      conventional metheds.
This study will focus on monitoring renal after transplantation using all US advanced
      technology.

      Aim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the
      gold standard.

      Aim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness.

      Aim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in
      three groups.

      Duration: 18 Months; participants will have a patient information sheet; once they are happy
      to participate, consent will be obtained.

      Study data will be entered into a database encrypted and stored in the department. Only the
      study principal investigator (PI) will know the study database password.
observational model: Cohort
time perspective: Prospective
measure: Peak systolic velocity (cm/s).
time frame: 12 weeks
description: Pean of the blood flow velocities in the artery/ vein peak systolic velocity ≥200 cm/s velocity difference between pre- and post-stenotic segments of 2:1
measure: Peak systolic velocity ratio (PSVR).
time frame: 12 weeks
description: High velocity flow at the stenosis site divided by a reference velocity (normal before stenosis)
measure: Resistive Index (RI).
time frame: 12 weeks
description: An RI less than 0.7 to 0.8 is considered normal, more than that it is indicator of transplant dysfunction.
measure: Volumetric stenosis.
time frame: 12 weeks
description: Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.
measure: 3D GSM.
time frame: 12 weeks
description: Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.
arm group label: Transplanted kidney
description: No intervention is required. Routine Doppler assessment + 3D scan + Shear wave elastography + MicrFlow Imaging will be immediately recorded afterwards
intervention type: Device
intervention name: 3D imaging
description: The study will focus on the accuracy of ultrasound technology in assessing renal transplants.
The entire assessment should not take more than 25 minutes.
arm group label: Transplanted kidney
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohammed Aslam, PhD
role: Study Director
affiliation: Academic Supervisor
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Renal Insufficiency
mesh term: Renal Artery Obstruction
sharing ipd: No