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/NCT06022952</url>
    </required_header>
    <id_info>
      <org_study_id>Stone_MD_forgotten_stent</org_study_id>
      <nct_id>NCT06022952</nct_id>
    </id_info>
    <brief_title>The Impact of the &quot;Stone MD&quot; Mobile App on the Prevention of Forgotten Ureteral Stents</brief_title>
    <official_title>Randomized, Single Center Controlled Trial of the Effect of the &quot;Stone MD&quot; Mobile App on the Prevention of Forgotten Ureteral Stents in Patients With Urolithiasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>St. Petersburg State Pavlov Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>St. Petersburg State Pavlov Medical University</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>
        The Impact of the &quot;Stone MD&quot; Mobile App on the Prevention of Forgotten Ureteral Stents&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Inclusion Criteria:&#xD;
  &#xD;
        1. Male and female patients aged 18 to 80 years who have a Ch 4.7-6.0 polyurethane ureteral&#xD;
        stent&#xD;
  &#xD;
        Exclusion Criteria:&#xD;
  &#xD;
          1. Active phase of urinary tract infection&#xD;
  &#xD;
          2. Insufficient level of social adaptation&#xD;
  &#xD;
          3. The patient does not have a smartphone with Internet access&#xD;
  &#xD;
        All patients will be randomized into 2 groups:&#xD;
  &#xD;
          -  group A - patients who used the Stone MD mobile application&#xD;
  &#xD;
          -  group B - patients who did not use the mobile application Patients are to be assigned a&#xD;
             randomization number that will match their treatment. Block randomization using 10&#xD;
             blocks is to be performed by a central randomization organization (www.randomize.net)&#xD;
             using a computerized algorithm.&#xD;
  &#xD;
        &quot;Stent Radar&quot; - part of the &quot;Stone MD&quot; mobile application. This tool is designed for the&#xD;
        patient to remove the ureteral stent using a mobile application within the time period&#xD;
        prescribed by the doctor. After the operation, the patient independently enters the data&#xD;
        related to the installation of the stent in the Stent Radar section of the Stone MD mobile&#xD;
        application. This data includes: the name of the stent, the side of insertion, and the&#xD;
        estimated date of removal. In a few days, a push notification appears in the application&#xD;
        stating that it is necessary to consult a doctor for the timely removal of the stent. Thus,&#xD;
        it is almost impossible to forget to remove the stent.&#xD;
  &#xD;
        At discharge, we strongly recommend that all patients install the Stone MD mobile app on&#xD;
        their smartphone. In the postoperative period, all patients will be monitored. In the event&#xD;
        that 2 weeks after the expected date of removal, the patient does not get in touch, he will&#xD;
        receive a call from the clinic, reminding him of the necessary visit (to remove the stent).&#xD;
  &#xD;
        Primary assessed outcomes:&#xD;
  &#xD;
          1. Number of patients who removed the stent on time in both groups&#xD;
  &#xD;
          2. Number of patients who delayed stent removal in both groups (less than 14 days)&#xD;
  &#xD;
          3. Number of patients who forgot to remove the stent in both groups (removed the stent more&#xD;
             than 14 days from the expected date of removal)&#xD;
  &#xD;
        Secondary assessed outcomes:&#xD;
  &#xD;
        1. Assessment of Stone-free status after surgery by performing computed tomography of kidneys&#xD;
        and urinary tract without intravenous contrasting 1 month after surgery&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Removed on time</measure>
      <time_frame>30 days</time_frame>
      <description>Number of patients who removed the stent on time in both groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Delayed stent removal</measure>
      <time_frame>30 days</time_frame>
      <description>Number of patients who delayed stent removal in both groups (less than 14 days)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Forgotten stent removal</measure>
      <time_frame>30 days</time_frame>
      <description>Number of patients who forgot to remove the stent in both groups (removed the stent more than 14 days from the expected date of removal)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Urolithiasis</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients who have used the Stone MD mobile app</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients who have not used the Stone MD mobile app</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Stone MD stent radar</intervention_name>
      <description>Mobile app</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1. Male and female patients aged 18 to 80 years who have a Ch 4.7-6.0 polyurethane ureteral&#xD;
          stent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Active phase of urinary tract infection&#xD;
  &#xD;
            2. Insufficient level of social adaptation&#xD;
  &#xD;
            3. The patient does not have a smartphone with Internet access&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>First Pavlov Saint Petersburg University</name>
        <address>
          <city>Saint Petersburg</city>
          <zip>197342</zip>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dmitriy Gorelov, MD</last_name>
        <phone>+79217964892</phone>
        <email>dsgorelov@mail.ru</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Saint Petersburg State University Hospital</name>
        <address>
          <city>Saint Petersburg</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nariman Gadzhiev, MD</last_name>
        <phone>+79214311436</phone>
        <email>nariman.gadjiev@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 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>Urolithiasis</mesh_term>
      <mesh_term>Urinary Calculi</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06022952
  org study id: Stone_MD_forgotten_stent
  nct id: NCT06022952
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents
  Inclusion Criteria:
  
        1. Male and female patients aged 18 to 80 years who have a Ch 4.7-6.0 polyurethane ureteral
        stent
  
        Exclusion Criteria:
  
          1. Active phase of urinary tract infection
  
          2. Insufficient level of social adaptation
  
          3. The patient does not have a smartphone with Internet access
  
        All patients will be randomized into 2 groups:
  
          -  group A - patients who used the Stone MD mobile application
  
          -  group B - patients who did not use the mobile application Patients are to be assigned a
             randomization number that will match their treatment. Block randomization using 10
             blocks is to be performed by a central randomization organization (www.randomize.net)
             using a computerized algorithm.
  
        "Stent Radar" - part of the "Stone MD" mobile application. This tool is designed for the
        patient to remove the ureteral stent using a mobile application within the time period
        prescribed by the doctor. After the operation, the patient independently enters the data
        related to the installation of the stent in the Stent Radar section of the Stone MD mobile
        application. This data includes: the name of the stent, the side of insertion, and the
        estimated date of removal. In a few days, a push notification appears in the application
        stating that it is necessary to consult a doctor for the timely removal of the stent. Thus,
        it is almost impossible to forget to remove the stent.
  
        At discharge, we strongly recommend that all patients install the Stone MD mobile app on
        their smartphone. In the postoperative period, all patients will be monitored. In the event
        that 2 weeks after the expected date of removal, the patient does not get in touch, he will
        receive a call from the clinic, reminding him of the necessary visit (to remove the stent).
  
        Primary assessed outcomes:
  
          1. Number of patients who removed the stent on time in both groups
  
          2. Number of patients who delayed stent removal in both groups (less than 14 days)
  
          3. Number of patients who forgot to remove the stent in both groups (removed the stent more
             than 14 days from the expected date of removal)
  
        Secondary assessed outcomes:
  
        1. Assessment of Stone-free status after surgery by performing computed tomography of kidneys
        and urinary tract without intravenous contrasting 1 month after surgery
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Removed on time
  time frame: 30 days
  description: Number of patients who removed the stent on time in both groups
  measure: Delayed stent removal
  time frame: 30 days
  description: Number of patients who delayed stent removal in both groups (less than 14 days)
  measure: Forgotten stent removal
  time frame: 30 days
  description: Number of patients who forgot to remove the stent in both groups (removed the stent more than 14 days from the expected date of removal)
  arm group label: Group A
  arm group type: Active Comparator
  description: Patients who have used the Stone MD mobile app
  arm group label: Group B
  arm group type: Active Comparator
  description: Patients who have not used the Stone MD mobile app
  intervention type: Other
  intervention name: Stone MD stent radar
  description: Mobile app
  arm group label: Group A
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Russian Federation
  responsible party type: Sponsor
  mesh term: Urolithiasis
  mesh term: Urinary Calculi
  sharing ipd: Undecided