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/NCT06026072</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/21/0124</org_study_id>
      <secondary_id>2021-A00807-34</secondary_id>
      <nct_id>NCT06026072</nct_id>
    </id_info>
    <brief_title>Validation of the CLAD Score Ifor Renal Colic Pain</brief_title>
    <acronym>CLAD-V</acronym>
    <official_title>Prospective Validation of the CLAD Score in Patients Admitted to an Emergency Facility for Renal Colic Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Toulouse</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>
        Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room&#xD;
        admissions.&#xD;
  &#xD;
        This study would validate the performance of the CLAD score in predicting the need for&#xD;
        surgical management within 7 days of patients admitted to the emergency department for renal&#xD;
        colic pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room&#xD;
        admissions. It results clinically in a lumbo-abdominal pain syndrome radiating into the&#xD;
        genitals. The origin of this pain is the tensioning of the urinary tract, most frequently by&#xD;
        a lithiasis creating a transient obstruction&#xD;
  &#xD;
        Toulouse medical team has developed the &quot;Complicated uroLithiasis and Alternative Diagnosis&quot;&#xD;
        (CLAD) score, which predicts the risk of requiring surgery within 7 days of admission of&#xD;
        patients to the emergency room for renal colic&#xD;
  &#xD;
        The aim of this study is to validate this CLAD-V score by collecting the elements of the CLAD&#xD;
        score and the clinician's intuition is made available to practitioners in the emergency&#xD;
        department.&#xD;
  &#xD;
        All patients presenting to the emergency room for renal colic pain are eligible. The doctor&#xD;
        in charge of the patient will have to examine him and take care of him according to the&#xD;
        service protocol. The doctor must then complete the questionnaire provided.&#xD;
  &#xD;
        A reminder of the patient on D7 is carried out to collect information on the need for surgery&#xD;
        after the emergency or not.&#xD;
  &#xD;
        Each center ensures inclusions and reminders on D7 and will only transmit the database&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 6, 2021</start_date>
    <completion_date type="Actual">July 30, 2023</completion_date>
    <primary_completion_date type="Actual">July 6, 2023</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>
      <intervention_model_description>The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. He will also completed the CLAD-V score and gives his intuition on the surgical outcome of the patient</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>CLAD-V performance</measure>
      <time_frame>7 days</time_frame>
      <description>Validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">1200</enrollment>
    <condition>Renal Colic</condition>
    <arm_group>
      <arm_group_label>CLAD-V</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All patient with renal colic will be eligible. The CLAD-V score will fills by the doctor and seven days after the patient will call back to know if he had a surgical intervention or no.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CLAD-V SCORE</intervention_name>
      <description>the CLAD-V score is measured by the doctor during the emergency take care. After 7 days the patient will be call back to compare the prediction of CLAD-V score and the reality of surgical intervention or no.</description>
      <arm_group_label>CLAD-V</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients admitted to the emergency room for suspected renal colic&#xD;
  &#xD;
            -  Patient not objecting to participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients unable to express their non-objection&#xD;
  &#xD;
            -  Pregnant women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Frederic BALEN</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Toulouse</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>CHU de Toulouse</name>
        <address>
          <city>Toulouse</city>
          <state>Haute-Garonne</state>
          <zip>31059</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colic</mesh_term>
      <mesh_term>Renal Colic</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/NCT06026072
  org study id: RC31/21/0124
  secondary id: 2021-A00807-34
  nct id: NCT06026072
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room
        admissions.
  
        This study would validate the performance of the CLAD score in predicting the need for
        surgical management within 7 days of patients admitted to the emergency department for renal
        colic pain.
  Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room
        admissions. It results clinically in a lumbo-abdominal pain syndrome radiating into the
        genitals. The origin of this pain is the tensioning of the urinary tract, most frequently by
        a lithiasis creating a transient obstruction
  
        Toulouse medical team has developed the "Complicated uroLithiasis and Alternative Diagnosis"
        (CLAD) score, which predicts the risk of requiring surgery within 7 days of admission of
        patients to the emergency room for renal colic
  
        The aim of this study is to validate this CLAD-V score by collecting the elements of the CLAD
        score and the clinician's intuition is made available to practitioners in the emergency
        department.
  
        All patients presenting to the emergency room for renal colic pain are eligible. The doctor
        in charge of the patient will have to examine him and take care of him according to the
        service protocol. The doctor must then complete the questionnaire provided.
  
        A reminder of the patient on D7 is carried out to collect information on the need for surgery
        after the emergency or not.
  
        Each center ensures inclusions and reminders on D7 and will only transmit the database
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. He will also completed the CLAD-V score and gives his intuition on the surgical outcome of the patient
  primary purpose: Prevention
  masking: None (Open Label)
  measure: CLAD-V performance
  time frame: 7 days
  description: Validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain
  arm group label: CLAD-V
  arm group type: Other
  description: All patient with renal colic will be eligible. The CLAD-V score will fills by the doctor and seven days after the patient will call back to know if he had a surgical intervention or no.
  intervention type: Other
  intervention name: CLAD-V SCORE
  description: the CLAD-V score is measured by the doctor during the emergency take care. After 7 days the patient will be call back to compare the prediction of CLAD-V score and the reality of surgical intervention or no.
  arm group label: CLAD-V
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Frederic BALEN
  role: Principal Investigator
  affiliation: University Hospital, Toulouse
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Colic
  mesh term: Renal Colic