xml: <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/NCT05986812</url>
    </required_header>
    <id_info>
      <org_study_id>Renal Elastography</org_study_id>
      <nct_id>NCT05986812</nct_id>
    </id_info>
    <brief_title>SWE in Assessment of CKD Patients</brief_title>
    <official_title>Feasibility of Shear Wave Elastography in Assessment of Renal Stiffness in Chronic Kidney Diseased Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Elastography is a developing technique to assess tissue elasticity. It is software that can&#xD;
        be integrated to the ultrasonography machines. Shear wave Elastography (SWE) is an&#xD;
        Elastography technique that does not require external pressure on the tissue and supplies&#xD;
        quantitative data. It uses real-time short-duration acoustic push pulse to generate shear&#xD;
        waves that propagate perpendicular to the main ultrasound beam. When the waves hit the&#xD;
        targeted tissue, the tissue is &quot;pushed&quot; in the direction of propagation, causing it to&#xD;
        temporarily deform or displace. The ultrasound scanner can monitor the tissue displacement,&#xD;
        measuring the time-to-peak displacement and the recovery time. Shear wave velocity increases&#xD;
        in diseased tissues, which can be significantly stiffer than normal ones. The parameters are&#xD;
        expressed in pressure units of kilopascals (kPa) and velocity (m s-1). SWE have been used to&#xD;
        study breast, thyroid, prostate and liver diseases. However, the application of SWE in&#xD;
        assessment of renal fibrosis in CKD patients is still unclear.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 25, 2023</start_date>
    <completion_date type="Anticipated">October 24, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 25, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The primary outcome of the study is the difference in renal SWE values between normal subjects and CKD patients .</measure>
      <time_frame>From 2 to 3 years</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Elastography ,CKD Patients</condition>
    <arm_group>
      <arm_group_label>Normal subjects</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Diseased subjects</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          CKD patients which ages from 18 to 75 years old&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patients are those older than 18 years diagnosed with CKD based on the KDIGO&#xD;
               (Kidney Disease Improving Global Outcomes) definition i.e. eGFR less than 60 mL/min&#xD;
               and/or the presence of markers of kidney damage (pathological albuminuria of at least&#xD;
               30 mg per 24 hours or proteinuria, hematuria, casts) persisting for more than 3&#xD;
               months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients whose BMI &gt;35kg/m 2 Any condition that precludes visualization of the kidney&#xD;
               by ultrasound or transmission of shear waves as pregnancy or marked ascites patients&#xD;
               with surgical kidney problems like hydro or pyonephrosis patients unwilling to&#xD;
               complete the study. Patients with a history of renal replacement therapy&#xD;
               (hemodialysis, peritoneal dialysis) , renal transplant, or acute kidney injury within&#xD;
               the last 3 months Patients with cystic kidney disease Patients with renal masses&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Dina AbdAllah Noshy AbdAllah</investigator_full_name>
      <investigator_title>Dina AbdAllah</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986812
  org study id: Renal Elastography
  nct id: NCT05986812
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Elastography is a developing technique to assess tissue elasticity. It is software that can
        be integrated to the ultrasonography machines. Shear wave Elastography (SWE) is an
        Elastography technique that does not require external pressure on the tissue and supplies
        quantitative data. It uses real-time short-duration acoustic push pulse to generate shear
        waves that propagate perpendicular to the main ultrasound beam. When the waves hit the
        targeted tissue, the tissue is "pushed" in the direction of propagation, causing it to
        temporarily deform or displace. The ultrasound scanner can monitor the tissue displacement,
        measuring the time-to-peak displacement and the recovery time. Shear wave velocity increases
        in diseased tissues, which can be significantly stiffer than normal ones. The parameters are
        expressed in pressure units of kilopascals (kPa) and velocity (m s-1). SWE have been used to
        study breast, thyroid, prostate and liver diseases. However, the application of SWE in
        assessment of renal fibrosis in CKD patients is still unclear.
  observational model: Case-Control
  time perspective: Retrospective
  measure: The primary outcome of the study is the difference in renal SWE values between normal subjects and CKD patients .
  time frame: From 2 to 3 years
  arm group label: Normal subjects
  arm group label: Diseased subjects
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Dina AbdAllah Noshy AbdAllah
  investigator title: Dina AbdAllah