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/NCT06036667</url>
    </required_header>
    <id_info>
      <org_study_id>ID 2388</org_study_id>
      <nct_id>NCT06036667</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS</brief_title>
    <official_title>Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</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>
        The aim of the study is to evaluate efficacy and safety of &quot;Smart Coaxial drain&quot; (Redax TM,&#xD;
        Poggio Rusco, Mantova, Italia) in terms of total amount of effusion drained, incidence of&#xD;
        residual effusion at Chest X-Ray and patient's comfort in Uniportal- and Biportal-VATS upper&#xD;
        lobectomies.&#xD;
  &#xD;
        In particular, to evaluate in Uniportal-VATS upper lobectomies the efficacy and safety of&#xD;
        smart coaxial drains compared with standard silicone chest tubes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        At the end of lung surgery, usually surgeons placed one or more chest tubes. There are&#xD;
        several types of chest tubes and the type used by surgeons depends on centre avaiability/&#xD;
        local practice or surgeon choice etc...Coaxial smart drains are used in clinical practice&#xD;
        since several years in Thoracic Surgery. In thoracoscopic (VATS) surgery usually only one&#xD;
        chest tube is placed. In this study, we evaluate the efficacy of placement of 28Fr &quot;coaxial&#xD;
        smart drain&quot; chest tube versus 28 Fr standard chest tube after Uniportal- or Biportal-VATS&#xD;
        upper lobectomies in terms of total amount of effusion drained, incidence of residual&#xD;
        effusion at Chest X-Ray and patient's confort.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 5, 2019</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fluid output 1</measure>
      <time_frame>At 24 hours from surgery</time_frame>
      <description>Total fluid amount</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fluid output 2</measure>
      <time_frame>At 48 hours from surgery</time_frame>
      <description>Total fluid amount</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fluid output 3</measure>
      <time_frame>At 72 hours from surgery</time_frame>
      <description>Total fluid amount</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fluid output 4</measure>
      <time_frame>At 96 hours from surgery</time_frame>
      <description>Total fluid amount</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Residual pleural effusion at chest X-Ray</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>Residual pleural effusion at chest X-Ray before chest tube removal. The entity of pleural effusion is measured as &quot;intercostal spaces&quot;, counted on posterior costal arches</description>
    </primary_outcome>
    <primary_outcome>
      <measure>subcutaneous emphysema 1</measure>
      <time_frame>At 24 hours after surgery</time_frame>
      <description>incidence of subcutaneous emphysema</description>
    </primary_outcome>
    <primary_outcome>
      <measure>subcutaneous emphysema 2</measure>
      <time_frame>At 48 hours after surgery</time_frame>
      <description>incidence of subcutaneous emphysema</description>
    </primary_outcome>
    <primary_outcome>
      <measure>subcutaneous emphysema 3</measure>
      <time_frame>At 72 hours after surgery</time_frame>
      <description>incidence of subcutaneous emphysema</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Tube obstruction</measure>
      <time_frame>during chest tube removal procedure</time_frame>
      <description>tube obstructed by blood clots</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain related to chest tube 1</measure>
      <time_frame>At 24 hours after surgery</time_frame>
      <description>Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS&gt;4 and &lt;10 indicates moderate to severe pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain related to chest tube 2</measure>
      <time_frame>At 48 hours after surgery</time_frame>
      <description>Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS&gt;4 and &lt;10 indicates moderate to severe pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain related to chest tube 3</measure>
      <time_frame>At 72 hours after surgery</time_frame>
      <description>Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS&gt;4 and &lt;10 indicates moderate to severe pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain related to chest tube 4</measure>
      <time_frame>At 96 hours after surgery</time_frame>
      <description>Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS&gt;4 and &lt;10 indicates moderate to severe pain)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">177</enrollment>
    <condition>Pleural Effusion</condition>
    <condition>Video Assisted Thoracic Surgery</condition>
    <condition>Chest Tubes</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study group 1</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>28Fr &quot;coaxial smart drain&quot; chest tube</intervention_name>
      <description>To evaluate the efficacy of one 28Fr chest tube (&quot;coaxial smart drain&quot; versus standard chest tube according to local practice, types of drainage availability in each centre, surgeon's choice etc) after Uniportal- or Biportal-VATS upper lobectomies.</description>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_label>Study group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergone upper right or left lobectomy in Uniportal- or Biportal-VATS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients undergone open surgery&#xD;
  &#xD;
            -  Patients undergone middle or lower lobectomies&#xD;
  &#xD;
            -  Patients undergone chest wall/or wedge resections&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dania Nachira, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dania Nachira, MD</last_name>
      <phone>3295882588</phone>
      <email>dania.nachira@policlinicogemelli.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</name>
        <address>
          <city>Roma</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dania Nachira, MD</last_name>
        <email>dania.nachira@policlinicogemelli.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>February 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>Pleural Effusion</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06036667
  org study id: ID 2388
  nct id: NCT06036667
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to evaluate efficacy and safety of "Smart Coaxial drain" (Redax TM,
        Poggio Rusco, Mantova, Italia) in terms of total amount of effusion drained, incidence of
        residual effusion at Chest X-Ray and patient's comfort in Uniportal- and Biportal-VATS upper
        lobectomies.
  
        In particular, to evaluate in Uniportal-VATS upper lobectomies the efficacy and safety of
        smart coaxial drains compared with standard silicone chest tubes.
  At the end of lung surgery, usually surgeons placed one or more chest tubes. There are
        several types of chest tubes and the type used by surgeons depends on centre avaiability/
        local practice or surgeon choice etc...Coaxial smart drains are used in clinical practice
        since several years in Thoracic Surgery. In thoracoscopic (VATS) surgery usually only one
        chest tube is placed. In this study, we evaluate the efficacy of placement of 28Fr "coaxial
        smart drain" chest tube versus 28 Fr standard chest tube after Uniportal- or Biportal-VATS
        upper lobectomies in terms of total amount of effusion drained, incidence of residual
        effusion at Chest X-Ray and patient's confort.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Fluid output 1
  time frame: At 24 hours from surgery
  description: Total fluid amount
  measure: Fluid output 2
  time frame: At 48 hours from surgery
  description: Total fluid amount
  measure: Fluid output 3
  time frame: At 72 hours from surgery
  description: Total fluid amount
  measure: Fluid output 4
  time frame: At 96 hours from surgery
  description: Total fluid amount
  measure: Residual pleural effusion at chest X-Ray
  time frame: 72 hours after surgery
  description: Residual pleural effusion at chest X-Ray before chest tube removal. The entity of pleural effusion is measured as "intercostal spaces", counted on posterior costal arches
  measure: subcutaneous emphysema 1
  time frame: At 24 hours after surgery
  description: incidence of subcutaneous emphysema
  measure: subcutaneous emphysema 2
  time frame: At 48 hours after surgery
  description: incidence of subcutaneous emphysema
  measure: subcutaneous emphysema 3
  time frame: At 72 hours after surgery
  description: incidence of subcutaneous emphysema
  measure: Tube obstruction
  time frame: during chest tube removal procedure
  description: tube obstructed by blood clots
  measure: Pain related to chest tube 1
  time frame: At 24 hours after surgery
  description: Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain)
  measure: Pain related to chest tube 2
  time frame: At 48 hours after surgery
  description: Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain)
  measure: Pain related to chest tube 3
  time frame: At 72 hours after surgery
  description: Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain)
  measure: Pain related to chest tube 4
  time frame: At 96 hours after surgery
  description: Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain)
  arm group label: Study group
  arm group type: Experimental
  description: All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery
  arm group label: Study group 1
  arm group type: No Intervention
  description: All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery
  arm group label: Study group 2
  arm group type: Experimental
  description: All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery
  intervention type: Procedure
  intervention name: 28Fr "coaxial smart drain" chest tube
  description: To evaluate the efficacy of one 28Fr chest tube ("coaxial smart drain" versus standard chest tube according to local practice, types of drainage availability in each centre, surgeon's choice etc) after Uniportal- or Biportal-VATS upper lobectomies.
  arm group label: Study group
  arm group label: Study group 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Dania Nachira, MD
  role: Principal Investigator
  affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  last name: Dania Nachira, MD
  phone: 3295882588
  email: dania.nachira@policlinicogemelli.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Pleural Effusion
  sharing ipd: No