<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/NCT02224924</url>
  </required_header>
  <id_info>
    <org_study_id>14-141</org_study_id>
    <nct_id>NCT02224924</nct_id>
  </id_info>
  <brief_title>Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures</brief_title>
  <official_title>Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare two methods that are currently used at the end of a&#xD;
      CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the&#xD;
      chance of air leaking out of the hole. The two techniques consist of either injecting a very&#xD;
      small amount of your the blood called a blood patch into the biopsy hole or injecting a&#xD;
      gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed&#xD;
      into the body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will determine the rate of all pneumothoraces and those pneumothoraces requiring&#xD;
      treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry&#xD;
      at the end of the biopsy procedure. The data collected will be used to determine if there is&#xD;
      equal effectiveness in the reduction of pneumothorax rates from both interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2014</start_date>
  <completion_date type="Actual">January 11, 2023</completion_date>
  <primary_completion_date type="Actual">January 11, 2023</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the rate of pneumothorax</measure>
    <time_frame>2 years</time_frame>
    <description>within 2 hours following biopsy. Pneumothorax is observed on post procedure CT scan or on follow-up chest radiographs while the patient is in the recovery room, according to standard of care.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Lung Biopsy</condition>
  <arm_group>
    <arm_group_label>autologous blood patch injection (ABPI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ABPI</intervention_name>
    <description>If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.</description>
    <arm_group_label>autologous blood patch injection (ABPI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug</intervention_name>
    <description>If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.</description>
    <arm_group_label>BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Referred for CT guided biopsy of lung lesion&#xD;
&#xD;
          -  Target lesion of any size&#xD;
&#xD;
          -  Target lesion located 1.5 cm or more away from visceral pleura based on the needle&#xD;
             path&#xD;
&#xD;
          -  Skin thickness ≤7 cm (from skin to pleura)&#xD;
&#xD;
          -  Needle path without transgression of pleural fissure bleb, or bulla is possible&#xD;
&#xD;
          -  Coaxial biopsy technique using Angiotech 19-Gauge introducer needle&#xD;
&#xD;
          -  Needle length ≤15&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Passage through non-aerated lung or tissue&#xD;
&#xD;
          -  More than 1 biopsy on the same side requiring more than 1 pleural puncture&#xD;
&#xD;
          -  History of prior ipsilateral lung interventions including:&#xD;
&#xD;
          -  Chest tube placement&#xD;
&#xD;
          -  Surgery&#xD;
&#xD;
          -  Pleurodesis&#xD;
&#xD;
          -  Radiation treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amgad Moussa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Experimental: autologous blood patch injection (ABPI)</keyword>
  <keyword>Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug</keyword>
  <keyword>14-141</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumothorax</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/NCT02224924
org study id: 14-141
nct id: NCT02224924
lead sponsor: 
The purpose of this study is to compare two methods that are currently used at the end of a
      CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the
      chance of air leaking out of the hole. The two techniques consist of either injecting a very
      small amount of your the blood called a blood patch into the biopsy hole or injecting a
      gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed
      into the body.
This study will determine the rate of all pneumothoraces and those pneumothoraces requiring
      treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry
      at the end of the biopsy procedure. The data collected will be used to determine if there is
      equal effectiveness in the reduction of pneumothorax rates from both interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: the rate of pneumothorax
time frame: 2 years
description: within 2 hours following biopsy. Pneumothorax is observed on post procedure CT scan or on follow-up chest radiographs while the patient is in the recovery room, according to standard of care.
arm group label: autologous blood patch injection (ABPI)
arm group type: Active Comparator
arm group label: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
arm group type: Experimental
intervention type: Other
intervention name: ABPI
description: If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.
arm group label: autologous blood patch injection (ABPI)
intervention type: Device
intervention name: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
description: If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.
arm group label: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amgad Moussa, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Pneumothorax