<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/NCT02246348</url>
  </required_header>
  <id_info>
    <org_study_id>DOP22_2</org_study_id>
    <nct_id>NCT02246348</nct_id>
  </id_info>
  <brief_title>Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)</brief_title>
  <official_title>Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Echosense Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Echosense Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler&#xD;
      ultrasound system incorporating a special signal processing package; i.e. the transthoracic&#xD;
      parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often&#xD;
      develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may&#xD;
      provide important insight into pulmonary blood vessels characteristics by the LDS signals&#xD;
      that are related to pulmonary hypertension.&#xD;
&#xD;
      The TPD performance in detecting PAH in SSc patients will be assessed in the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low recruitment rate&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">August 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.</measure>
    <time_frame>12 month</time_frame>
    <description>Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension sevirity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical analysis success of the method in comparison to RHC data.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Systemic Sclerosis</condition>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Doppler ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Doppler ultrasound</intervention_name>
    <description>Recording Doppler ultrasound noninvasively from the right chest wall</description>
    <arm_group_label>Doppler ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able and willing to give signed informed consent prior to enrollment&#xD;
&#xD;
          2. Male or female, ≥ 18 years of age&#xD;
&#xD;
          3. Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den&#xD;
             Hoogen 2013): Score ≥ 9.&#xD;
&#xD;
          4. Patients with RHC data available from measurement within 3 weeks prior to TPD&#xD;
             assessment&#xD;
&#xD;
          5. No change in or initiation of PAH specific therapy between the last RHC and TPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. People unable or unwilling to give informed consent.&#xD;
&#xD;
          2. PCWP or LVEDP &gt; 15 mmHg&#xD;
&#xD;
          3. Any PH etiology outside Group 1 (Dana Point, 2008)&#xD;
&#xD;
          4. Pregnant women&#xD;
&#xD;
          5. Patients having 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>Alexsandra Balbir, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Reumatology department, Rambam medical center</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>January 20, 2016</last_update_submitted>
  <last_update_submitted_qc>January 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Systemic Sclerosis</keyword>
  <keyword>Pulmonary hypertension</keyword>
  <keyword>Lung Doppler signals</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Sclerosis</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/NCT02246348
org study id: DOP22_2
nct id: NCT02246348
lead sponsor: 
has dmc: No
Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler
      ultrasound system incorporating a special signal processing package; i.e. the transthoracic
      parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often
      develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may
      provide important insight into pulmonary blood vessels characteristics by the LDS signals
      that are related to pulmonary hypertension.

      The TPD performance in detecting PAH in SSc patients will be assessed in the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
time frame: 12 month
description: Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension sevirity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical analysis success of the method in comparison to RHC data.
arm group label: Doppler ultrasound
arm group type: Experimental
intervention type: Radiation
intervention name: Doppler ultrasound
description: Recording Doppler ultrasound noninvasively from the right chest wall
arm group label: Doppler ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexsandra Balbir, Dr
role: Principal Investigator
affiliation: Rambam Health Care Campus
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis