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/NCT06039410</url>
    </required_header>
    <id_info>
      <org_study_id>ISO0001</org_study_id>
      <nct_id>NCT06039410</nct_id>
    </id_info>
    <brief_title>A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.</brief_title>
    <official_title>ISO-101 a Novel Device for the Treatment of Orthostatic Hypotension - a Signal of Efficacy Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Isotech Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Newcastle-upon-Tyne Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Isotech Ltd</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>
        The goal of this clinical trial is to test a novel medical device (ISO-101) in patients&#xD;
        diagnosied with orthostatic hypotension. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  to determine whether the ISO-101 device demonstrates a signal of efficacy in people with&#xD;
             OH and whether it is worthy of further clinical evaluation.&#xD;
  &#xD;
          -  Assess the safety and performance of the ISO-101 device in patients with orthostatic&#xD;
             hypotension.&#xD;
  &#xD;
        Participants will use the device under controlled conditions and have the following&#xD;
        parameters measured before and after standing up:&#xD;
  &#xD;
          -  blood pressure&#xD;
  &#xD;
          -  markers of peripheal vascular resistence&#xD;
  &#xD;
          -  sympathetic nervous system activity measure before and after standing up&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a proof of principle study aimed at evaluating if there is a signal of efficacy from&#xD;
        use of the ISO-101 device in people with orthostatic hypotension. The study is a single&#xD;
        centre, unblinded, pre-post study. All participants will act as their own control, and all&#xD;
        will receive the intervention.The primary objective is to determine whether the ISO-101&#xD;
        device demonstrates a signal of efficacy in people with OH and whether it is worthy of&#xD;
        further clinical evaluation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>
      <intervention_model_description>Thus, the study is a single centre, unblinded, pre-post study. All participants will act as their own control, and all will receive the intervention.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood pressure (mmHg)</measure>
      <time_frame>From date of enrollment until end of study completion (24 hours)</time_frame>
      <description>The change in resting BP, standing BP and postural BP drop during and immediately after using the device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse Events</measure>
      <time_frame>From date of enrollment until end of study completion (24 hours)</time_frame>
      <description>Adverse events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>From date of enrollment until end of study completion (24 hours)</time_frame>
      <description>Magnitude and duration of treatment effect on blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular variablity</measure>
      <time_frame>From date of enrollment until end of study completion (24 hours)</time_frame>
      <description>Changes in peripheral vascular resistance (dyn*s*m2/cm5) and sympathetic nervous system activity (heart rate variability)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erganomics</measure>
      <time_frame>From date of enrollment until end of study completion (24 hours)</time_frame>
      <description>Number of participants able to effectively use the device</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post study participant questionaire</measure>
      <time_frame>From date of enrollment until end of study completion (24 hours)</time_frame>
      <description>7 point Likert Scale covering the following domains; usefulness, ease of use, ease of learning, satisfaction and intention to use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Investigator feedback</measure>
      <time_frame>From date of enrollment until end of study completion (24 hours)</time_frame>
      <description>Global impression score</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Orthostatic Hypotension</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ISO-101 Device</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ISO-101</intervention_name>
      <description>ISO-101 is an experimental wearable class 1 medical device which when used is able to raise the blood pressure upon standing via controlled isometric muscular contractions</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Willing and able to give informed consent for participation in the study&#xD;
  &#xD;
            -  Adults aged over 18 years with a clinical diagnosis of orthostatic hypotension&#xD;
  &#xD;
            -  A drop in systolic BP of ≥20 mmHg (with or without a drop in diastolic BP ≥10 mmHg)&#xD;
               within 3 minutes of standing up from a supine position&#xD;
  &#xD;
            -  Able to stand up from a supine position (with assistance if required)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cognitively unable to follow research procedures&#xD;
  &#xD;
            -  Physically unable to use the ISO-101 device (e.g., unilateral arm weakness due to&#xD;
               stroke)&#xD;
  &#xD;
            -  Acute or reversible cause of OH (e.g., haemorrhage or sepsis)&#xD;
  &#xD;
            -  Current pregnancy&#xD;
  &#xD;
            -  Participants on insulin (participants will be asked to refrain from breakfast on the&#xD;
               morning of their assessment)&#xD;
  &#xD;
            -  Resting supine systolic BP ≥180 or diastolic ≥110 mmHg&#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>Neil Fawkes, MBChB DPM FFPM</last_name>
      <phone>+44 (0) 2830 835 500</phone>
      <email>neil@isotechltd.co.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust</name>
        <address>
          <city>Newcastle Upon Tyne</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr Frith, MBChB FRCP PhD</last_name>
        <email>james.frith@newcastle.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypotension, Orthostatic</mesh_term>
      <mesh_term>Hypotension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06039410
  org study id: ISO0001
  nct id: NCT06039410
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test a novel medical device (ISO-101) in patients
        diagnosied with orthostatic hypotension. The main question[s] it aims to answer are:
  
          -  to determine whether the ISO-101 device demonstrates a signal of efficacy in people with
             OH and whether it is worthy of further clinical evaluation.
  
          -  Assess the safety and performance of the ISO-101 device in patients with orthostatic
             hypotension.
  
        Participants will use the device under controlled conditions and have the following
        parameters measured before and after standing up:
  
          -  blood pressure
  
          -  markers of peripheal vascular resistence
  
          -  sympathetic nervous system activity measure before and after standing up
  This is a proof of principle study aimed at evaluating if there is a signal of efficacy from
        use of the ISO-101 device in people with orthostatic hypotension. The study is a single
        centre, unblinded, pre-post study. All participants will act as their own control, and all
        will receive the intervention.The primary objective is to determine whether the ISO-101
        device demonstrates a signal of efficacy in people with OH and whether it is worthy of
        further clinical evaluation.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Thus, the study is a single centre, unblinded, pre-post study. All participants will act as their own control, and all will receive the intervention.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Blood pressure (mmHg)
  time frame: From date of enrollment until end of study completion (24 hours)
  description: The change in resting BP, standing BP and postural BP drop during and immediately after using the device.
  measure: Adverse Events
  time frame: From date of enrollment until end of study completion (24 hours)
  description: Adverse events
  measure: Blood pressure
  time frame: From date of enrollment until end of study completion (24 hours)
  description: Magnitude and duration of treatment effect on blood pressure
  measure: Cardiovascular variablity
  time frame: From date of enrollment until end of study completion (24 hours)
  description: Changes in peripheral vascular resistance (dyn*s*m2/cm5) and sympathetic nervous system activity (heart rate variability)
  measure: Erganomics
  time frame: From date of enrollment until end of study completion (24 hours)
  description: Number of participants able to effectively use the device
  measure: Post study participant questionaire
  time frame: From date of enrollment until end of study completion (24 hours)
  description: 7 point Likert Scale covering the following domains; usefulness, ease of use, ease of learning, satisfaction and intention to use
  measure: Investigator feedback
  time frame: From date of enrollment until end of study completion (24 hours)
  description: Global impression score
  arm group label: Treatment
  arm group type: Experimental
  description: ISO-101 Device
  intervention type: Device
  intervention name: ISO-101
  description: ISO-101 is an experimental wearable class 1 medical device which when used is able to raise the blood pressure upon standing via controlled isometric muscular contractions
  arm group label: Treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Neil Fawkes, MBChB DPM FFPM
  phone: +44 (0) 2830 835 500
  email: neil@isotechltd.co.uk
  facility: 
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Hypotension, Orthostatic
  mesh term: Hypotension
  sharing ipd: Undecided