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/NCT05975931</url>
    </required_header>
    <id_info>
      <org_study_id>LNE802</org_study_id>
      <nct_id>NCT05975931</nct_id>
    </id_info>
    <brief_title>IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.</brief_title>
    <acronym>IMPACT</acronym>
    <official_title>A Single-centre, Non-interventional, Retrospective Study to Describe the IMPACT of AspireSR® for Vagus Nerve Stimulation (VNS) Therapy on Healthcare Resource Utilisation and Clinical Outcomes.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>LivaNova</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>OPEN VIE Limited</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>LivaNova</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 is a retrospective non-interventional study to describe the HCRU and clinical outcomes&#xD;
        before and after AspireSR® device implantation in subjects with drug resistant epilepsy at&#xD;
        the Queen Elizabeth Hospital, Birmingham (QEHB).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Real-world data on healthcare resource use (HCRU) for subjects with treatment-resistant&#xD;
        epilepsy and their clinical outcome prior to- and post-VNS device implantation in the UK are&#xD;
        limited.&#xD;
  &#xD;
        The current study aims to describe and compare the secondary HCRU and clinical outcomes prior&#xD;
        to and following AspireSR® device implantation in subjects with drug resistant epilepsy.&#xD;
  &#xD;
        Retrospectively-collected data from hospital medical records (paper-based and/or electronic,&#xD;
        as appropriate) will be used to describe subject characteristics, disease control and&#xD;
        clinical outcomes. All secondary HCRU data will be extracted from the Hospital Episode&#xD;
        Statistics (HES) database by Harvey Walsh Ltd (HW, trading under OPEN VIE). Primary HCRU data&#xD;
        will be requested from the subjects' general practitioners (GPs).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Suspended</overall_status>
    <why_stopped>
      The study has been put on hold until Jan-24 because study team capacity not sufficient.&#xD;
    </why_stopped>
    <start_date type="Actual">January 20, 2022</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Descriptive comparison of healthcare resource use (HCRU)</measure>
      <time_frame>24 months before and after device implantation</time_frame>
      <description>Descriptive comparison of secondary HCRU in the 24 month periods before and after AspireSR® device implantation</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">229</enrollment>
    <condition>Epilepsy</condition>
    <arm_group>
      <arm_group_label>Cohort 1 (&quot;new insertions cohort&quot;)</arm_group_label>
      <description>Subjects who have had Aspire SR® implanted as their first VNS model.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2 (&quot;battery change cohort&quot;)</arm_group_label>
      <description>Subjects who have had their VNS battery changed from a previous model to Aspire SR®.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Male and female adult (aged ≥18 years at AspireSR® implantation) subjects with epilepsy who&#xD;
          have had the VNS device AspireSR® implanted at least 24 months prior to study retrospective&#xD;
          data collection.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years at AspireSR® device implantation.&#xD;
  &#xD;
            -  VNS device AspireSR® implantation for the first time or battery change from a previous&#xD;
               model to AspireSR® at least 24 months prior to the start of retrospective data&#xD;
               collection from medical records.&#xD;
  &#xD;
            -  Subjects for whom written informed consent has been provided for researcher access to&#xD;
               their medical records and extraction of data from HES (if the subject is living and&#xD;
               has capacity to consent) or advice from a consultee (if the subject is living but&#xD;
               lacks capacity to consent).&#xD;
  &#xD;
            -  Subjects with available medical history for at least 24 months prior to Aspire SR®&#xD;
               implantation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Living subjects for whom consent for researcher access to medical records and&#xD;
               extraction of data from HES has not been obtained.&#xD;
  &#xD;
            -  Deceased subjects.&#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>Barbara Wysota</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Queen Elizabeth Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Queen Elizabeth Hospital Birmingham</name>
        <address>
          <city>Birmingham</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>VNS</keyword>
    <keyword>Drug Resistant Epilepsy</keyword>
    <keyword>Vagus Nerve Stimulation</keyword>
    <keyword>AspireSR®</keyword>
    <keyword>Health Care Utilization</keyword>
    <keyword>DRE</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epilepsy</mesh_term>
    </condition_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/NCT05975931
  org study id: LNE802
  nct id: NCT05975931
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a retrospective non-interventional study to describe the HCRU and clinical outcomes
        before and after AspireSR® device implantation in subjects with drug resistant epilepsy at
        the Queen Elizabeth Hospital, Birmingham (QEHB).
  Real-world data on healthcare resource use (HCRU) for subjects with treatment-resistant
        epilepsy and their clinical outcome prior to- and post-VNS device implantation in the UK are
        limited.
  
        The current study aims to describe and compare the secondary HCRU and clinical outcomes prior
        to and following AspireSR® device implantation in subjects with drug resistant epilepsy.
  
        Retrospectively-collected data from hospital medical records (paper-based and/or electronic,
        as appropriate) will be used to describe subject characteristics, disease control and
        clinical outcomes. All secondary HCRU data will be extracted from the Hospital Episode
        Statistics (HES) database by Harvey Walsh Ltd (HW, trading under OPEN VIE). Primary HCRU data
        will be requested from the subjects' general practitioners (GPs).
  observational model: Other
  time perspective: Retrospective
  measure: Descriptive comparison of healthcare resource use (HCRU)
  time frame: 24 months before and after device implantation
  description: Descriptive comparison of secondary HCRU in the 24 month periods before and after AspireSR® device implantation
  arm group label: Cohort 1 ("new insertions cohort")
  description: Subjects who have had Aspire SR® implanted as their first VNS model.
  arm group label: Cohort 2 ("battery change cohort")
  description: Subjects who have had their VNS battery changed from a previous model to Aspire SR®.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Barbara Wysota
  role: Principal Investigator
  affiliation: The Queen Elizabeth Hospital
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Epilepsy