<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/NCT02192801</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-13-RC-0022-13-CTIL</org_study_id>
    <nct_id>NCT02192801</nct_id>
  </id_info>
  <brief_title>Kidney Function in Patients With Bladder Exstrophy</brief_title>
  <official_title>Evaluation of Long-term Renal Function in Patients After Surgical Repair of Classical Bladder Exstrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with classical bladder exstrophy undergo many surgical interventions with secondary&#xD;
      urinary tract infections complicating their course. lately primary definitive surgical&#xD;
      correction of this congenital anomaly has been implemented with satisfactory results.&#xD;
      Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical&#xD;
      surgical complications can potentially damage their kidneys in the long-term. therefore we&#xD;
      decided to evaluate renal function in the long-term in these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <primary_completion_date type="Anticipated">April 2016</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>Renal function</measure>
    <time_frame>1 day (last visit )</time_frame>
    <description>Creatinine and GFR estimation , proteinuria, albuminuria will be assessed as measures of renal function as well as renal mass estimation through renal size as by ultrasound and in certain cases through dimercaptosucicnic acid (DMSA)renal scan</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Classic Bladder Exstrophy</condition>
  <condition>Renal Function</condition>
  <condition>GFR</condition>
  <condition>Proteinuria</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with calssic bladder exstrophy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with classic bladder exstrophy treated and followed in Pediatric urology&#xD;
             clinic in Dana Children Hospital and Outpatient Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Roxana Cleper, MD</last_name>
    <phone>972-3-6972512</phone>
    <email>roxanac@tlvmc.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jacob Ben Chaim, MD</last_name>
    <email>jacobbc@tlvmc.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Pediatric Outpatient Clinic Dana Children Hospital Tel Aviv Sourasky medical center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Jacob Ben Chaim, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>January 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Classic Bladder Exstrophy</keyword>
  <keyword>Renal function</keyword>
  <keyword>GFR</keyword>
  <keyword>Proteinuria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Proteinuria</mesh_term>
    <mesh_term>Bladder Exstrophy</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/NCT02192801
org study id: TASMC-13-RC-0022-13-CTIL
nct id: NCT02192801
lead sponsor: 
has dmc: No
Patients with classical bladder exstrophy undergo many surgical interventions with secondary
      urinary tract infections complicating their course. lately primary definitive surgical
      correction of this congenital anomaly has been implemented with satisfactory results.
      Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical
      surgical complications can potentially damage their kidneys in the long-term. therefore we
      decided to evaluate renal function in the long-term in these patients.
observational model: Cohort
time perspective: Prospective
measure: Renal function
time frame: 1 day (last visit )
description: Creatinine and GFR estimation , proteinuria, albuminuria will be assessed as measures of renal function as well as renal mass estimation through renal size as by ultrasound and in certain cases through dimercaptosucicnic acid (DMSA)renal scan
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 30 Years
healthy volunteers: No
last name: Roxana Cleper, MD
phone: 972-3-6972512
email: roxanac@tlvmc.gov.il
last name: Jacob Ben Chaim, MD
email: jacobbc@tlvmc.gov.il
facility: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Proteinuria
mesh term: Bladder Exstrophy