<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/NCT02227732</url>
  </required_header>
  <id_info>
    <org_study_id>CS-IS-VH-13-001</org_study_id>
    <secondary_id>CI20130054</secondary_id>
    <nct_id>NCT02227732</nct_id>
  </id_info>
  <brief_title>A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>CareFusion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CareFusion</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a new catheter is safe and effective in&#xD;
      treating malignant pleural effusions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device -related safety and the number of adverse events.</measure>
    <time_frame>28 days post catheter insertion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>pleurodesis success</measure>
    <time_frame>14 days</time_frame>
    <description>Assessed by chest x-ray, thorachic ultrasound, and confirmation the catheter is patent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pleurodesis success</measure>
    <time_frame>28 days</time_frame>
    <description>Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pleurodesis success</measure>
    <time_frame>60 days</time_frame>
    <description>Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Breathlesness</measure>
    <time_frame>14, 28, 60 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Chest Pain</measure>
    <time_frame>14, 28, 60 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Time to pleurodesis</measure>
    <time_frame>14, 28, 60 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life</measure>
    <time_frame>14, 28, 60 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Need for further pleural intervention post catheter removal</measure>
    <time_frame>60 days</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Malignant Pleural Effusions</condition>
  <arm_group>
    <arm_group_label>New Indwelling Pleural Catheter</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>New Indwelling Pleural Catheter</intervention_name>
    <description>Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution.</description>
    <arm_group_label>New Indwelling Pleural Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is ≥ 18 years old.&#xD;
&#xD;
          2. Subject has a symptomatic malignant pleural effusion requiring intervention. For an&#xD;
             effusion to be defined as malignant, at least one of the following must be true:&#xD;
&#xD;
               -  There is histocytological confirmation of pleural malignancy&#xD;
&#xD;
               -  The effusion is an exudate (as per Light's criteria) in the context of&#xD;
                  histocytologically proven malignancy elsewhere, with no other clear cause for&#xD;
                  fluid identified&#xD;
&#xD;
          3. Subject has a history of at least one ipsilateral pleural effusion causing dyspnoea&#xD;
             that responded to thoracentesis where the lung expanded and the dyspnoea was relieved.&#xD;
&#xD;
          4. Subject is willing and able to provide written informed consent.&#xD;
&#xD;
          5. Subject is willing and able to meet all study requirements, including attending&#xD;
             follow-up visits or receiving trial-related telephone calls.&#xD;
&#xD;
          6. There is sufficient fluid on thoracic ultrasound to allow safe insertion of an&#xD;
             indwelling pleural catheter&#xD;
&#xD;
          7. Negative pregnancy test if appropriate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has significant trapped lung (&gt;20%), or a proximal bronchial obstruction which&#xD;
             is likely to lead to trapped lung.&#xD;
&#xD;
          2. Subject has a Karnofsky score of less than 50, or a WHO/ECOG performance status of 3*&#xD;
             or more.&#xD;
&#xD;
          3. Subject is pregnant, planning to become pregnant, or is lactating.&#xD;
&#xD;
          4. Subject has a history of empyema.&#xD;
&#xD;
          5. Subject has a history of chylothorax.&#xD;
&#xD;
          6. Subject has an uncorrected coagulopathy.&#xD;
&#xD;
          7. Subject is allergic to device materials.&#xD;
&#xD;
          8. Subject has evidence, in the opinion of the Chief Investigator, of either on-going&#xD;
             systemic or pleural infection.&#xD;
&#xD;
          9. Subject has had a lobectomy or pneumonectomy on the side of the effusion.&#xD;
&#xD;
         10. Subject has undergone a previous attempt at pleurodesis which has failed.&#xD;
&#xD;
         11. Subject has previously been diagnosed with a serious immunodeficiency disorder.&#xD;
&#xD;
         12. Subject has bilateral pleural effusions, with both being at least moderate in size&#xD;
             (greater than 1/3 of the hemithorax on chest x-ray).&#xD;
&#xD;
         13. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely&#xD;
             to be futile.&#xD;
&#xD;
         14. Subject has a mediastinal shift of ≥2cm toward the side of the effusion.&#xD;
&#xD;
         15. Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the&#xD;
             ipsilateral chest.&#xD;
&#xD;
         16. Subject has any clinical condition, diagnosis, or social circumstance that, in the&#xD;
             opinion of the Chief Investigator, would mean participation in the study would be&#xD;
             contraindicated.&#xD;
&#xD;
         17. Subject has no access to a telephone&#xD;
&#xD;
         18. No details of blood values (full blood count, clotting screen, urea and electrolytes,&#xD;
             liver function) from within the last 10 days * Patients who have a performance status&#xD;
             of 3 may be considered for the trial if the removal of their fluid would likely&#xD;
             improve their performance score by 1 or more.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Southmead Hospital - Academic Resporatory Unit</name>
      <address>
        <city>Westbury on Severn</city>
        <state>Bristol</state>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</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, Malignant</mesh_term>
    <mesh_term>Pleural Effusion</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/NCT02227732
org study id: CS-IS-VH-13-001
secondary id: CI20130054
nct id: NCT02227732
lead sponsor: 
The purpose of this study is to determine whether a new catheter is safe and effective in
      treating malignant pleural effusions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Device -related safety and the number of adverse events.
time frame: 28 days post catheter insertion
measure: pleurodesis success
time frame: 14 days
description: Assessed by chest x-ray, thorachic ultrasound, and confirmation the catheter is patent.
measure: Pleurodesis success
time frame: 28 days
description: Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.
measure: pleurodesis success
time frame: 60 days
description: Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.
measure: Breathlesness
time frame: 14, 28, 60 days
measure: Chest Pain
time frame: 14, 28, 60 days
measure: Time to pleurodesis
time frame: 14, 28, 60 days
measure: Quality of Life
time frame: 14, 28, 60 days
measure: Need for further pleural intervention post catheter removal
time frame: 60 days
arm group label: New Indwelling Pleural Catheter
arm group type: Other
intervention type: Device
intervention name: New Indwelling Pleural Catheter
description: Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution.
arm group label: New Indwelling Pleural Catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Pleural Effusion, Malignant
mesh term: Pleural Effusion