<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/NCT01728662</url>
  </required_header>
  <id_info>
    <org_study_id>RMC127000 CTIL</org_study_id>
    <nct_id>NCT01728662</nct_id>
  </id_info>
  <brief_title>Emphysematous Lung Sealant Therapy in Homogeneous Emphysema</brief_title>
  <official_title>Post Market Investigator Sponsored Study of Emphysematous Lung Sealant Therapy in Homogeneous Emphysema Using a Modified Treatment Strategy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test that hypothesis that endoscopic lung volume reduction therapy performed&#xD;
      using emphysematous lung sealant treatment can be improved using smaller doses delivered to&#xD;
      more a larger number of treatment sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an investigational, single arm, physician-sponsored study that will be conducted at&#xD;
      Rabin Medical Center under the direction of Professor Mordechai Kramer. Patients will receive&#xD;
      AeriSeal System therapy using a new treatment algorithm to deliver approved foam sealant&#xD;
      components at doses at or below those previously shown to be safe and effective during prior&#xD;
      studies. Investigational aspects of this study involve only the method of administration of&#xD;
      material, not the material itself. The specific modifications to the treatment method&#xD;
      proposed in this study include: 1) lowering the dose per subsegment of AeriSeal System Foam&#xD;
      Sealant to 10 mL from the approved 20 mL dose; 2) administering the subsegmental doses at&#xD;
      more anatomic locations with the goal of improving distribution of material and achieving&#xD;
      more effective lung volume reduction; 3) eliminating the administration of air through the&#xD;
      instrument channel of the bronchoscope following Foam Sealant delivery to simply and shorten&#xD;
      the procedure, improving safety.&#xD;
&#xD;
      The study is designed to treat 8 patients. The first 4 patients will receive treatment with&#xD;
      10 mL of AeriSeal System Foam Sealant administered at 6 subsegments, 3 in each upper lobe (a&#xD;
      dose of 60 mL of AeriSeal Foam Sealant). This group will be followed until all 4 have&#xD;
      completed 1 month (28 day) follow-up. A safety review of the data will then be conducted&#xD;
      prior to initiating treatment in the next group of 4 patients. This review will include an&#xD;
      assessment of adverse events and physiological responses.&#xD;
&#xD;
      Assuming no emergent safety issues are identified, the next group of 4 patients will receive&#xD;
      treatment with 10 mL of AeriSeal System Foam Sealant administered at 8 subsegments, 3 in each&#xD;
      upper lobe, one in the upper-most portion of the right middle lobe, one in the upper-most&#xD;
      portion of the lingual (a dose of 80 mL of AeriSeal Foam Sealant).&#xD;
&#xD;
      All patients will be followed for 24 weeks after completion of therapy and receive standard&#xD;
      medical treatment in addition to treatment with the AeriSeal System.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>Overall safety assessment</measure>
    <time_frame>6 months</time_frame>
    <description>Overall assessment of safety based on review&#xD;
Clinical and laboratory results:&#xD;
Serious Adverse Events (SAEs)&#xD;
Serious Adverse Device Effects (SADEs)&#xD;
Unanticipated Serious Adverse Device Effects (USADEs)&#xD;
Physical Examinations&#xD;
Vital signs&#xD;
Serum chemistry and hematology.&#xD;
Changes from baseline in clinical pathology or lung physiology based on:&#xD;
Blood gases&#xD;
Pulmonary function data&#xD;
Radiology data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy Evaluations will include:</measure>
    <time_frame>6 months</time_frame>
    <description>CT evidence of lobar volume reduction at site(s) of AeriSeal administration at 12 weeks assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.&#xD;
Change from baseline at 12 and 24 weeks in RV/TLC&#xD;
Change from baseline at 12 and 24 weeks in FEV1&#xD;
Change from baseline at 12 and 24 weeks in FVC&#xD;
Change from baseline at 12 and 24 weeks in 6 MWT&#xD;
Change from baseline at 12 and 24 weeks in MRCD score&#xD;
Change from baseline at 12 and 24 weeks in SGRQ total domain score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Patients With Advanced Homogeneous Emphysema</condition>
  <arm_group>
    <arm_group_label>ELVR Procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single subsegmental AeriSeal System treatment consists of the administration of 10 mL Foam Sealant administered through a standard fiberoptic bronchoscope via an administration syringe and bronchoscopic catheter into the target area of damaged lung</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ELVR Procedure</intervention_name>
    <description>Lung Volume Reduction Procedure</description>
    <arm_group_label>ELVR Procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have a diagnosis of GOLD Stage III/IV homogeneous emphysema&#xD;
&#xD;
          2. FEV1/FVC &lt;70 % predicted, FEV1 of &lt; 50% predicted, TLC &gt; 100% of predicted, and RV &gt;&#xD;
             150% predicted.&#xD;
&#xD;
          3. chest CT scan showing evidence of tissue destruction indicative of homogeneous&#xD;
             (uniformly distributed) emphysema.&#xD;
&#xD;
          4. Patients must also have ≤ 15% perfusion in both upper lobes on a quantitative lung&#xD;
             perfusion scan indicating bilateral target sites for therapy.&#xD;
&#xD;
          5. Patients must be &gt; 40 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Alpha-1 antitrypsin deficient patients (i.e. those with serum levels &lt; 80 mg/dL, or &lt;&#xD;
             11 µmol/L or 57 mg/dL).&#xD;
&#xD;
          2. patients who are pregnant or breast feeding.&#xD;
&#xD;
          3. patients who are smoking.&#xD;
&#xD;
          4. patients using other investigational medications will be excluded.&#xD;
&#xD;
          5. Patients must have persistent symptoms despite medical therapy and either not be&#xD;
             candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo&#xD;
             LVRS.&#xD;
&#xD;
          6. have no significant co-morbid conditions that could influence study outcomes or their&#xD;
             ability to tolerate bronchoscopy.&#xD;
&#xD;
          7. Specifically, patients should not have a history of prior major thoracic surgery, HIV&#xD;
             infection, clinically significant asthma, bronchiectasis, pulmonary hypertension or&#xD;
             coronary heart disease.&#xD;
&#xD;
          8. Patients must also not be dependent on medications that could increase the risk of&#xD;
             undergoing treatment or adversely effect the chance of recovering from treatment (i.e.&#xD;
             high dose steroids, immunosuppressive agents, or anticoagulants)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mordechai R Kramer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rabin Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mordechai R Kramer, MD</last_name>
    <email>kremerm@clalit.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Mordechai R Kramer, MD</last_name>
    </contact>
    <investigator>
      <last_name>Mordechai R Kramer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>emphysema</keyword>
  <keyword>lung volume reduction therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Emphysema</mesh_term>
    <mesh_term>Emphysema</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/NCT01728662
org study id: RMC127000 CTIL
nct id: NCT01728662
lead sponsor: 
has dmc: No
This study will test that hypothesis that endoscopic lung volume reduction therapy performed
      using emphysematous lung sealant treatment can be improved using smaller doses delivered to
      more a larger number of treatment sites.
This is an investigational, single arm, physician-sponsored study that will be conducted at
      Rabin Medical Center under the direction of Professor Mordechai Kramer. Patients will receive
      AeriSeal System therapy using a new treatment algorithm to deliver approved foam sealant
      components at doses at or below those previously shown to be safe and effective during prior
      studies. Investigational aspects of this study involve only the method of administration of
      material, not the material itself. The specific modifications to the treatment method
      proposed in this study include: 1) lowering the dose per subsegment of AeriSeal System Foam
      Sealant to 10 mL from the approved 20 mL dose; 2) administering the subsegmental doses at
      more anatomic locations with the goal of improving distribution of material and achieving
      more effective lung volume reduction; 3) eliminating the administration of air through the
      instrument channel of the bronchoscope following Foam Sealant delivery to simply and shorten
      the procedure, improving safety.

      The study is designed to treat 8 patients. The first 4 patients will receive treatment with
      10 mL of AeriSeal System Foam Sealant administered at 6 subsegments, 3 in each upper lobe (a
      dose of 60 mL of AeriSeal Foam Sealant). This group will be followed until all 4 have
      completed 1 month (28 day) follow-up. A safety review of the data will then be conducted
      prior to initiating treatment in the next group of 4 patients. This review will include an
      assessment of adverse events and physiological responses.

      Assuming no emergent safety issues are identified, the next group of 4 patients will receive
      treatment with 10 mL of AeriSeal System Foam Sealant administered at 8 subsegments, 3 in each
      upper lobe, one in the upper-most portion of the right middle lobe, one in the upper-most
      portion of the lingual (a dose of 80 mL of AeriSeal Foam Sealant).

      All patients will be followed for 24 weeks after completion of therapy and receive standard
      medical treatment in addition to treatment with the AeriSeal System.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall safety assessment
time frame: 6 months
description: Overall assessment of safety based on review
Clinical and laboratory results:
Serious Adverse Events (SAEs)
Serious Adverse Device Effects (SADEs)
Unanticipated Serious Adverse Device Effects (USADEs)
Physical Examinations
Vital signs
Serum chemistry and hematology.
Changes from baseline in clinical pathology or lung physiology based on:
Blood gases
Pulmonary function data
Radiology data
measure: Efficacy Evaluations will include:
time frame: 6 months
description: CT evidence of lobar volume reduction at site(s) of AeriSeal administration at 12 weeks assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.
Change from baseline at 12 and 24 weeks in RV/TLC
Change from baseline at 12 and 24 weeks in FEV1
Change from baseline at 12 and 24 weeks in FVC
Change from baseline at 12 and 24 weeks in 6 MWT
Change from baseline at 12 and 24 weeks in MRCD score
Change from baseline at 12 and 24 weeks in SGRQ total domain score
arm group label: ELVR Procedure
arm group type: Experimental
description: A single subsegmental AeriSeal System treatment consists of the administration of 10 mL Foam Sealant administered through a standard fiberoptic bronchoscope via an administration syringe and bronchoscopic catheter into the target area of damaged lung
intervention type: Procedure
intervention name: ELVR Procedure
description: Lung Volume Reduction Procedure
arm group label: ELVR Procedure
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Mordechai R Kramer, MD
role: Principal Investigator
affiliation: Rabin Medical Center
last name: Mordechai R Kramer, MD
email: kremerm@clalit.org.il
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Pulmonary Emphysema
mesh term: Emphysema