<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/NCT03272815</url>
  </required_header>
  <id_info>
    <org_study_id>109205</org_study_id>
    <nct_id>NCT03272815</nct_id>
  </id_info>
  <brief_title>Percussion Device (PD) for Detection of Pneumothorax</brief_title>
  <official_title>Evaluation of a Novel Point-of-care Percussion Device (PD) for Detection of Pneumothorax in Patients Following Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</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>
      This study aims to examine the safety and efficacy of the Percussion Device in detecting a&#xD;
      pneumothorax in patients that have undergone thoracic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, non-randomized clinical feasibility cohort study. The purpose of this&#xD;
      feasibility study is to collect preliminary performance and safety information for the&#xD;
      Percussion Device (PD). Patients satisfying the inclusion criteria will be approached for&#xD;
      study enrolment before their surgery in clinic. Following surgery and after the patient's&#xD;
      chest tube has been removed, evaluation of the chest using the PD and ultrasound will be&#xD;
      performed by two independent assessors (a nurse practitioner or resident on the Thoracic&#xD;
      Surgery Team) prior to the post-removal CXR. Details of study procedure are details in&#xD;
      section 2.8. The PD's performance metric will be compared against CXR results, which is&#xD;
      considered the gold standard in diagnosing a pneumothorax.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Device requires further modification&#xD;
  </why_stopped>
  <start_date type="Actual">May 10, 2018</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</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>Single Group Assignment</intervention_model>
    <intervention_model_description>A prospective clinical feasibility cohort study.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Radiologists are unaware of the intervention or the nature of the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Performance metrics</measure>
    <time_frame>2 years</time_frame>
    <description>Performance metrics of the PD in detecting the presence of a pneumothorax following the removal of the last chest tube in patients that have undergone thoracic surgery compared to the CXR reported by a blinded radiologist unaware of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inter-rater reliability</measure>
    <time_frame>2 years</time_frame>
    <description>The secondary outcomes will include inter-rater reliability with the PD or ultrasound or CXR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>2 years</time_frame>
    <description>Any adverse event associated with the PD or ultrasound or CXR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Marginal Costs</measure>
    <time_frame>2 years</time_frame>
    <description>Marginal costs differences between the surgeon performed PD and CXR will be based on an overall risk-benefit assessment that will take into account accuracy and costs of facilities as well as physician services.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Pneumothorax</condition>
  <arm_group>
    <arm_group_label>PD arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing assessment of the chest with the percussion device (PD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing assessment of the chest with the ultrasound (US).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percussion Device (PD)</intervention_name>
    <description>A laboratory prototype of the Percussion Device (PD) has been designed and built; laboratory data collection software, signal analysis and classification algorithms have been developed. It has been designed to detect a pneumothorax.</description>
    <arm_group_label>PD arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound (US)</intervention_name>
    <description>The SonoSite hand help portable ultrasound device.</description>
    <arm_group_label>US arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients that have undergone an open or thoracoscopic thoracic procedure requiring&#xD;
             a chest tube at London Health Sciences Centre (LHSC), London, Ontario.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years old Patients unable to consent Patients with known&#xD;
             persistent pneumothorax prior to chest tube removal Patients who are pregnant Patients&#xD;
             with severe chest wall deformity.&#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>Richard Malthaner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Richard Malthaner</investigator_full_name>
    <investigator_title>Thoracic Surgeon</investigator_title>
  </responsible_party>
  <keyword>pneumothorax</keyword>
  <keyword>chest tube removal</keyword>
  <keyword>percussion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumothorax</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03272815
org study id: 109205
nct id: NCT03272815
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to examine the safety and efficacy of the Percussion Device in detecting a
      pneumothorax in patients that have undergone thoracic surgery.
A prospective, non-randomized clinical feasibility cohort study. The purpose of this
      feasibility study is to collect preliminary performance and safety information for the
      Percussion Device (PD). Patients satisfying the inclusion criteria will be approached for
      study enrolment before their surgery in clinic. Following surgery and after the patient's
      chest tube has been removed, evaluation of the chest using the PD and ultrasound will be
      performed by two independent assessors (a nurse practitioner or resident on the Thoracic
      Surgery Team) prior to the post-removal CXR. Details of study procedure are details in
      section 2.8. The PD's performance metric will be compared against CXR results, which is
      considered the gold standard in diagnosing a pneumothorax.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: A prospective clinical feasibility cohort study.
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
masking description: Radiologists are unaware of the intervention or the nature of the study.
measure: Performance metrics
time frame: 2 years
description: Performance metrics of the PD in detecting the presence of a pneumothorax following the removal of the last chest tube in patients that have undergone thoracic surgery compared to the CXR reported by a blinded radiologist unaware of the study.
measure: Inter-rater reliability
time frame: 2 years
description: The secondary outcomes will include inter-rater reliability with the PD or ultrasound or CXR.
measure: Adverse Events
time frame: 2 years
description: Any adverse event associated with the PD or ultrasound or CXR.
measure: Marginal Costs
time frame: 2 years
description: Marginal costs differences between the surgeon performed PD and CXR will be based on an overall risk-benefit assessment that will take into account accuracy and costs of facilities as well as physician services.
arm group label: PD arm
arm group type: Experimental
description: Patients undergoing assessment of the chest with the percussion device (PD).
arm group label: US arm
arm group type: Active Comparator
description: Patients undergoing assessment of the chest with the ultrasound (US).
intervention type: Device
intervention name: Percussion Device (PD)
description: A laboratory prototype of the Percussion Device (PD) has been designed and built; laboratory data collection software, signal analysis and classification algorithms have been developed. It has been designed to detect a pneumothorax.
arm group label: PD arm
intervention type: Device
intervention name: Ultrasound (US)
description: The SonoSite hand help portable ultrasound device.
arm group label: US arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Malthaner, MD
role: Principal Investigator
affiliation: Lawson Health Research Institute
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Richard Malthaner
investigator title: Thoracic Surgeon
mesh term: Pneumothorax
sharing ipd: No