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/NCT05971719</url>
    </required_header>
    <id_info>
      <org_study_id>2024-11574</org_study_id>
      <nct_id>NCT05971719</nct_id>
    </id_info>
    <brief_title>Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks</brief_title>
    <acronym>CT0136</acronym>
    <official_title>Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre hospitalier de l'Université de Montréal (CHUM)</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>
        Air leaks represent one of the most common complications and postoperative morbidity in&#xD;
        thoracic surgery. Air leaks have been associated with the largest preventable morbidity&#xD;
        associated with increased costs following lobectomy (typically related to increased length of&#xD;
        stay). However, the standard used to detect and localize the air leaks, the submersion test,&#xD;
        is not suitable for the standard surgical procedure, Video Assisted Thoracic Surgery.&#xD;
        Considering the prevalence of this complication and the absence of a surgical standard of&#xD;
        care for such complications, the aim of this study is to develop a system to create and send&#xD;
        a glycerine aerosol smoke in the lungs of the patient. The smoke is visible with standard&#xD;
        laparoscope and will flow though the pulmonary leak, thereby reducing postoperative surgical&#xD;
        complications, morbidity, and length of stay for patients undergoing pulmonary resection.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2027</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Localization efficacy</measure>
      <time_frame>48 months</time_frame>
      <description>Puncture the lungs to achieve an average size air leak (1-2 cm) and ask the surgeon to identify the airleak with the localization system. Register a success if the surgeon has properly localized the air leak and a failure if the surgeon has failed to localize the air leak. Destinguish the failures in false positive (Air leak detected in a non leaking area of the lung) and false negative (Air leak not detected when present). Compare that efficacy rate to the efficacy of a similar experiement done with the submersion technique.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of localization</measure>
      <time_frame>48 months</time_frame>
      <description>Mesure the time required for the surgeon to localize the air leak area by the surgeon. Compare that time to the submertion test localization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimal leak localizable</measure>
      <time_frame>48 months</time_frame>
      <description>Puncture the lungs with different needle sizes and ask a surgeon to localize the air leaks on the lung. Record the smallest hole the surgeon was able to localize with our system. Then, compare the minimal leak localizable with our system to the minimal leak localizable with the submersion test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Staple lines airtightness</measure>
      <time_frame>48 months</time_frame>
      <description>Staple lines are known to not consistently give an airtight closure. But the manufacturers of those staple lines do not know why they are failing. Prove that the system can detect if the staple line is airtight or not, which could be useful for those manufacturers as well as for the clinicians. As leaks won't be created on every staple line, confirm that there is a leak by creating bubbles with saline at the staple line on the ex-vivo lung. Ask a surgeon to give the outcome of the airtightness of the staple line (success or failure) and then, compare the outcome to what we obtained with the localisation system.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Air Leak From Lung</condition>
    <arm_group>
      <arm_group_label>Air Leaks</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. To establish a standard protocol to use our system we will use a dark box to validate that our system is able to localize the air leaks and to establish the best way to use the system. A one centimeter leak will be created on the lung with a scalpel. A laparoscope will be introduced via a trocar in the dark box and the surgeon will be asked to localize the leaks. The detection will be recorded via the laparoscope. The goal will be to perform a standardized protocol to use the system smoothly and efficiently on ex-vivo human lungs.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Air Leaks: Aerosol glycerine System</intervention_name>
      <description>A range of different leak will be done with different needle sizes on the lung. Perform localization on staple lines used surgically during pulmonary surgeries, as they are known to not consistently give an airtight closure. The lung will be put in the ex-vivo model and ask for a surgeon to localize the leaks with our system. The needle incisions will be repeat on another lung and ask the same surgeon to localize the leaks with the submersion test. To perform the submersion test the surgeon will have to submerge the lung in saline solution and to check the presence of air bubbles. The lung is inflated to pressures of 20 to 40 cm H209. The precision of both systems will be compared by the minimal incision the minimal incision the surgeon was able to localize.</description>
      <arm_group_label>Air Leaks</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing lung transplant surgery&#xD;
  &#xD;
            -  Organ donor ineligible to donate lungs&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Healthy individuals&#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_contact>
      <last_name>Moishe Liberman, MD</last_name>
      <phone>514-890-8000</phone>
      <phone_ext>26832</phone_ext>
      <email>moishe.liberman@umontreal.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Adeline Jouquan, MSc</last_name>
      <phone>514-890-8000</phone>
      <phone_ext>26214</phone_ext>
      <email>adeline.jouquan.chum@ssss.gouv.qc.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHUM</name>
        <address>
          <city>Montréal</city>
          <zip>H2X 0A9</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Moishe Liberman, MD</last_name>
        <phone>514-890-8000</phone>
        <phone_ext>26832</phone_ext>
        <email>moishe.liberman@umontreal.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glycerol</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05971719
  org study id: 2024-11574
  nct id: NCT05971719
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Air leaks represent one of the most common complications and postoperative morbidity in
        thoracic surgery. Air leaks have been associated with the largest preventable morbidity
        associated with increased costs following lobectomy (typically related to increased length of
        stay). However, the standard used to detect and localize the air leaks, the submersion test,
        is not suitable for the standard surgical procedure, Video Assisted Thoracic Surgery.
        Considering the prevalence of this complication and the absence of a surgical standard of
        care for such complications, the aim of this study is to develop a system to create and send
        a glycerine aerosol smoke in the lungs of the patient. The smoke is visible with standard
        laparoscope and will flow though the pulmonary leak, thereby reducing postoperative surgical
        complications, morbidity, and length of stay for patients undergoing pulmonary resection.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Localization efficacy
  time frame: 48 months
  description: Puncture the lungs to achieve an average size air leak (1-2 cm) and ask the surgeon to identify the airleak with the localization system. Register a success if the surgeon has properly localized the air leak and a failure if the surgeon has failed to localize the air leak. Destinguish the failures in false positive (Air leak detected in a non leaking area of the lung) and false negative (Air leak not detected when present). Compare that efficacy rate to the efficacy of a similar experiement done with the submersion technique.
  measure: Duration of localization
  time frame: 48 months
  description: Mesure the time required for the surgeon to localize the air leak area by the surgeon. Compare that time to the submertion test localization.
  measure: Minimal leak localizable
  time frame: 48 months
  description: Puncture the lungs with different needle sizes and ask a surgeon to localize the air leaks on the lung. Record the smallest hole the surgeon was able to localize with our system. Then, compare the minimal leak localizable with our system to the minimal leak localizable with the submersion test.
  measure: Staple lines airtightness
  time frame: 48 months
  description: Staple lines are known to not consistently give an airtight closure. But the manufacturers of those staple lines do not know why they are failing. Prove that the system can detect if the staple line is airtight or not, which could be useful for those manufacturers as well as for the clinicians. As leaks won't be created on every staple line, confirm that there is a leak by creating bubbles with saline at the staple line on the ex-vivo lung. Ask a surgeon to give the outcome of the airtightness of the staple line (success or failure) and then, compare the outcome to what we obtained with the localisation system.
  arm group label: Air Leaks
  arm group type: Experimental
  description: Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. To establish a standard protocol to use our system we will use a dark box to validate that our system is able to localize the air leaks and to establish the best way to use the system. A one centimeter leak will be created on the lung with a scalpel. A laparoscope will be introduced via a trocar in the dark box and the surgeon will be asked to localize the leaks. The detection will be recorded via the laparoscope. The goal will be to perform a standardized protocol to use the system smoothly and efficiently on ex-vivo human lungs.
  intervention type: Diagnostic Test
  intervention name: Air Leaks: Aerosol glycerine System
  description: A range of different leak will be done with different needle sizes on the lung. Perform localization on staple lines used surgically during pulmonary surgeries, as they are known to not consistently give an airtight closure. The lung will be put in the ex-vivo model and ask for a surgeon to localize the leaks with our system. The needle incisions will be repeat on another lung and ask the same surgeon to localize the leaks with the submersion test. To perform the submersion test the surgeon will have to submerge the lung in saline solution and to check the presence of air bubbles. The lung is inflated to pressures of 20 to 40 cm H209. The precision of both systems will be compared by the minimal incision the minimal incision the surgeon was able to localize.
  arm group label: Air Leaks
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Moishe Liberman, MD
  phone: 514-890-8000
  phone ext: 26832
  email: moishe.liberman@umontreal.ca
  last name: Adeline Jouquan, MSc
  phone: 514-890-8000
  phone ext: 26214
  email: adeline.jouquan.chum@ssss.gouv.qc.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Glycerol