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/NCT05995652</url>
    </required_header>
    <id_info>
      <org_study_id>Abdelrahim Elsherbiny</org_study_id>
      <nct_id>NCT05995652</nct_id>
    </id_info>
    <brief_title>Can Shear Wave Elastography Predict the Success of ESWL: a Prospective Study</brief_title>
    <official_title>Can Shear Wave Elastography Predict the Success of Shock-Wave Lithotripsy Used in Renal Stones Treatment: a Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Abdelrahim Elsherbiny</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Can Shear Wave Elastography predict the success of Shock-Wave Lithotripsy used in renal&#xD;
        stones treatment ? A prospective study&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Extracorporeal shock-wave lithotripsy (ESWL) is the noninvasive treatment method that is&#xD;
        recommended as the first choice in the treatment of small and medium sized renal stones and&#xD;
        proximal ureteral stones.&#xD;
  &#xD;
        This study is a trial to determine the predictive role of shear wave elastography in the&#xD;
        success of ESWL management of kidney stones.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>stone free rate</measure>
      <time_frame>1 month</time_frame>
      <description>post ESWL</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Kidney Stone</condition>
    <arm_group>
      <arm_group_label>ESWL sucess and failed gps</arm_group_label>
      <description>post ESWL 50 pt large gp will be devided into sucess gp and failed gp</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>elastography</intervention_name>
      <description>elastography</description>
      <arm_group_label>ESWL sucess and failed gps</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          1 gp of 50 pts will be subjected to ESWL and will be divided into 2 other gps success and&#xD;
          failed&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients more than 18 years&#xD;
  &#xD;
            -  With single radiopaque renal stone&#xD;
  &#xD;
            -  Ranging in size from (1-1,5 cm) for ESWL.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any urological abnormal anatomy&#xD;
  &#xD;
            -  Lower calyceal stone more than 1cm&#xD;
  &#xD;
            -  Impaired renal functions&#xD;
  &#xD;
            -  Uncorrected coagulopathy.&#xD;
  &#xD;
            -  Active UTI Pregnancy Single kidney Multiple stones&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>tarek elzayat, prof.dr.</last_name>
      <role>Study Chair</role>
      <affiliation>AinShams</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>abdelrahim elsherbiny, investigator</last_name>
      <phone>01093447104</phone>
      <email>abdelrahim.elsherbiny@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>mohamed samir, investigator</last_name>
      <phone>01016703707</phone>
      <email>mohsamir2002@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of Medicine Ain Shams University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>abdelrahim elsherbiny, investigator</last_name>
        <phone>01093447104</phone>
        <email>abdelrahim.elsherbiny@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Prof. Dr. Tarek Mostafa Abd-Elmageed El-Zayat</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Prof. Dr. Noha Mohamed Diaa Eldin Ahmed</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Prof. Dr. Diaa Eldin Mahmoud Abdel-Fattah</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Prof. Dr. Mohamed Samir Sayed</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Abdelrahim Elsherbiny</investigator_full_name>
      <investigator_title>assistant lecturer at urology department, Ain shams university</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Calculi</mesh_term>
    </condition_browse>
    <!-- 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/NCT05995652
  org study id: Abdelrahim Elsherbiny
  nct id: NCT05995652
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Can Shear Wave Elastography predict the success of Shock-Wave Lithotripsy used in renal
        stones treatment ? A prospective study
  Extracorporeal shock-wave lithotripsy (ESWL) is the noninvasive treatment method that is
        recommended as the first choice in the treatment of small and medium sized renal stones and
        proximal ureteral stones.
  
        This study is a trial to determine the predictive role of shear wave elastography in the
        success of ESWL management of kidney stones.
  observational model: Cohort
  time perspective: Prospective
  measure: stone free rate
  time frame: 1 month
  description: post ESWL
  arm group label: ESWL sucess and failed gps
  description: post ESWL 50 pt large gp will be devided into sucess gp and failed gp
  intervention type: Procedure
  intervention name: elastography
  description: elastography
  arm group label: ESWL sucess and failed gps
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: tarek elzayat, prof.dr.
  role: Study Chair
  affiliation: AinShams
  last name: abdelrahim elsherbiny, investigator
  phone: 01093447104
  email: abdelrahim.elsherbiny@gmail.com
  last name: mohamed samir, investigator
  phone: 01016703707
  email: mohsamir2002@gmail.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Abdelrahim Elsherbiny
  investigator title: assistant lecturer at urology department, Ain shams university
  mesh term: Kidney Calculi