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/NCT05987904</url>
    </required_header>
    <id_info>
      <org_study_id>MDR LP-I-CARDIAG</org_study_id>
      <nct_id>NCT05987904</nct_id>
    </id_info>
    <brief_title>Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk Assessment With the LynxPatch Device</brief_title>
    <acronym>LP-I-CARDIAG</acronym>
    <official_title>MDR - Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lynx Health Science GmbH</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Meditrial Europe Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Lynx Health Science GmbH</source>
    <oversight_info>
      <has_dmc>Yes</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>
        In this clinical study the investigators will evaluate if it is feasible to pre-operatively&#xD;
        identify low-risk patients, and to identify patients with cardiac pathologies with the&#xD;
        LynxPatch.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The LynxPatch is a non-invasive, wireless device for cardiac diagnosis. The aim of this study&#xD;
        is to compare the LynxPatch predictions with the echocardiographic diagnoses of cardiac&#xD;
        pathologies and to evaluate its perioperative risk predictions in non-cardiac surgeries. The&#xD;
        study population includes 1100 patients that scheduled for an echocardiographic assessment or&#xD;
        for a non-cardiac surgery. The LynxPatch measurement procedure has a duration of about 30&#xD;
        minutes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.</measure>
      <time_frame>30 minutes per individual</time_frame>
      <description>Comparison of the detection of the presence of a cardiac pathology by the LynxPatch device and by echocardiography-based expert diagnosis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Accuracy of the LynxPatch device predictions of an adverse perioperative outcome</measure>
      <time_frame>30 days per individual</time_frame>
      <description>Comparison of the LynxPatch device predictions of an adverse perioperative outcome with actually occuring adverse perioperative outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usability of the LynxPatch device</measure>
      <time_frame>30 minutes per individual</time_frame>
      <description>Evaluation of aspects of the LynxPatch device's usability by interviewing study participants using a questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of LynxPatch-related safety incidents</measure>
      <time_frame>30 minutes per individual</time_frame>
      <description>Assessment of safety-related aspects with the LynxPatch device. Relevant incidents include Adverse Device Effects, Serious Adverse Device Effects and Device Defficiencies.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1100</enrollment>
    <condition>Cardiovascular Diseases</condition>
    <condition>Heart Diseases</condition>
    <arm_group>
      <arm_group_label>Group 1: Cardiologic Group</arm_group_label>
      <description>This group includes patients who are scheduled for echocardiography.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: Surgery Group</arm_group_label>
      <description>This group includes patients that are scheduled for non-cardiac surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>LynxPatch</intervention_name>
      <description>Measurements with the LynxPatch device are conducted.</description>
      <arm_group_label>Group 1: Cardiologic Group</arm_group_label>
      <arm_group_label>Group 2: Surgery Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          In this study, all patients will be consecutively recruited that are either scheduled for&#xD;
          an echocardiographic examination or that will be subjected to a non-cardiac surgical&#xD;
          procedure according to their respective standard procedure.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provision of informed consent, i.e., the subject must be able to understand and sign&#xD;
               the Patient Information and Consent Form.&#xD;
  &#xD;
            -  Group 1: Patients that have an indication for an echocardiographic assessment.&#xD;
  &#xD;
            -  Group 2: Patients that are scheduled for a non-cardiac surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects has implanted cardioverter defibrillator&#xD;
  &#xD;
            -  Subject is pregnant&#xD;
  &#xD;
            -  Subject is breastfeeding&#xD;
  &#xD;
            -  Subject has compromised skin in the location where the LynxPatch is intended to be&#xD;
               positioned&#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>Aydan Ewers, Dr. med.</last_name>
      <role>Principal Investigator</role>
      <affiliation>BG Universitätsklinikum Bergmannsheil</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael Klum</last_name>
      <phone>49 30 814504401</phone>
      <email>klum@lynx-health.science</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Timo Tigges</last_name>
      <email>tigges@lynx-health.science</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cardiac Diagnosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Heart Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05987904
  org study id: MDR LP-I-CARDIAG
  nct id: NCT05987904
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In this clinical study the investigators will evaluate if it is feasible to pre-operatively
        identify low-risk patients, and to identify patients with cardiac pathologies with the
        LynxPatch.
  The LynxPatch is a non-invasive, wireless device for cardiac diagnosis. The aim of this study
        is to compare the LynxPatch predictions with the echocardiographic diagnoses of cardiac
        pathologies and to evaluate its perioperative risk predictions in non-cardiac surgeries. The
        study population includes 1100 patients that scheduled for an echocardiographic assessment or
        for a non-cardiac surgery. The LynxPatch measurement procedure has a duration of about 30
        minutes.
  observational model: Case-Only
  time perspective: Prospective
  measure: Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.
  time frame: 30 minutes per individual
  description: Comparison of the detection of the presence of a cardiac pathology by the LynxPatch device and by echocardiography-based expert diagnosis.
  measure: Accuracy of the LynxPatch device predictions of an adverse perioperative outcome
  time frame: 30 days per individual
  description: Comparison of the LynxPatch device predictions of an adverse perioperative outcome with actually occuring adverse perioperative outcome.
  measure: Usability of the LynxPatch device
  time frame: 30 minutes per individual
  description: Evaluation of aspects of the LynxPatch device's usability by interviewing study participants using a questionnaire.
  measure: Rate of LynxPatch-related safety incidents
  time frame: 30 minutes per individual
  description: Assessment of safety-related aspects with the LynxPatch device. Relevant incidents include Adverse Device Effects, Serious Adverse Device Effects and Device Defficiencies.
  arm group label: Group 1: Cardiologic Group
  description: This group includes patients who are scheduled for echocardiography.
  arm group label: Group 2: Surgery Group
  description: This group includes patients that are scheduled for non-cardiac surgery.
  intervention type: Device
  intervention name: LynxPatch
  description: Measurements with the LynxPatch device are conducted.
  arm group label: Group 1: Cardiologic Group
  arm group label: Group 2: Surgery Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Aydan Ewers, Dr. med.
  role: Principal Investigator
  affiliation: BG Universitätsklinikum Bergmannsheil
  last name: Michael Klum
  phone: 49 30 814504401
  email: klum@lynx-health.science
  last name: Timo Tigges
  email: tigges@lynx-health.science
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  mesh term: Heart Diseases
  sharing ipd: No