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/NCT06003205</url>
    </required_header>
    <id_info>
      <org_study_id>DOC1040A COBI</org_study_id>
      <nct_id>NCT06003205</nct_id>
    </id_info>
    <brief_title>Contributing Factors to Local Bioimpedance Spectroscopy</brief_title>
    <acronym>COBI</acronym>
    <official_title>Assessment of Contributing Factors to Local Bioimpedance Spectroscopy Using a Wearable Sensor: An Intervention Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mode Sensors AS</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Oslo University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Mode Sensors AS</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 an exploratory interventional study. The aim of the investigation is to identify and&#xD;
        quantify contributing factors to local bioimpedance spectroscopy (BIS) measured by a wearable&#xD;
        sensor patch, particularly the effect of fluid shifts caused by postural changes and lower&#xD;
        body negative pressure (LBNP).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigational devices (patches) will perform near-continuous measurements of&#xD;
        multifrequency bioimpedance (BIS), temperature, and body orientation (accelerometer) during&#xD;
        the entire period of wear (2 days). Patches will be mounted at the upper body (back and&#xD;
        thorax) and calf. The primary objective is to assess the effect of prolonged lower body&#xD;
        negative pressure (LBNP) on the BIS of the calf. The target population is healthy volunteers&#xD;
        between 18-50 years old.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Relative change in extracellular resistance of the calf from t0 to t1 (immediately before and after 40 minutes of LBNP at 30 mmHg), measured by the investigational bioimpedance device</measure>
      <time_frame>40 minutes</time_frame>
      <description>Relative change in extracellular resistance at the calf from before to after 40 minutes of lower body negative pressure, to assess the effect of prolonged LBNP.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in extracellular resistance at the upper back following postural changes, measured by the investigational bioimpedance device.</measure>
      <time_frame>6 hours</time_frame>
      <description>Relative change in extracellular resistance at the upper back following changes in posture</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in extracellular resistance at the upper back following application of three different external pressures.</measure>
      <time_frame>2 hours</time_frame>
      <description>Mean differences in extracellular resistance of the upper back, when the subject lays in a supine position on three different surfaces. Extracellular resistance is measured by the investigational bioimpedance device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency and severity of adverse device effects</measure>
      <time_frame>3 days</time_frame>
      <description>To assess the safety of the investigational device in healthy volunteers</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Fluid and Electrolyte Imbalance</condition>
    <condition>Overhydration</condition>
    <condition>Edema</condition>
    <arm_group>
      <arm_group_label>Wearable bioimpedance sensor</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All subjects will use the investigational device and undergo several interventions: lower body negative pressure (3-40 minutes at 30 mmHg), posture intervention, and pressure intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Wearable bioimpedance sensor</intervention_name>
      <description>The investigational device is an electronic bioimpedance-based, body-worn, battery-powered sensor intended to monitor changes in fluid volume. It is designed as an adhesive patch with four integrated electrodes.</description>
      <arm_group_label>Wearable bioimpedance sensor</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 to 50 years of age, at the time of signing the informed consent&#xD;
  &#xD;
            -  Overtly healthy as determined by medical evaluation including medical history,&#xD;
               physical examination and focused cardiac ultrasound.&#xD;
  &#xD;
            -  Use of adequate birth control for women of childbearing potential. Inclusion is&#xD;
               possible when an acceptable effective contraceptive measure is used (combined&#xD;
               (estrogen and progestogen containing) hormonal contraception, progestogen-only&#xD;
               hormonal contraception associated with inhibition of ovulation, intrauterine device,&#xD;
               intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner&#xD;
               or sexual abstinence).&#xD;
  &#xD;
            -  Capable of giving signed informed consent which includes compliance with the&#xD;
               requirements and restrictions listed in the informed consent form (ICF) and in this&#xD;
               protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives&#xD;
  &#xD;
            -  Breached skin at patch mounting area.&#xD;
  &#xD;
            -  Implantable pulse generators such as pacemakers and defibrillators, and/or use of&#xD;
               other electrical medical equipment for which an interaction effect with the&#xD;
               investigational device cannot be ruled out.&#xD;
  &#xD;
            -  Planned magnetic resonance (MR) imaging during the investigation period&#xD;
  &#xD;
            -  Any medical condition limiting physical exertional capacity or requiring regular&#xD;
               medication (allergy and contraceptives excepted).&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Breastfeeding&#xD;
  &#xD;
            -  History of syncope (syncope of presumed vasovagal nature with known precipitating&#xD;
               factor excepted).&#xD;
  &#xD;
            -  Any known cardiac disease that, at the investigator's discretion, warrants exclusion&#xD;
               from the study, including but not limited to cardiac arrhythmia, esophageal varices,&#xD;
               and aneurysms.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sigve N Aas, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Mode Sensors AS</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lars Ø Høiseth, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Oslo University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sigve N Aas, PhD</last_name>
      <phone>004741499074</phone>
      <email>sigve.aas@modesensors.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Frida Bremnes, M.Sc.</last_name>
      <email>frida.bremnes@modesensors.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Physiology lab. Aker hospital, Oslo University Hospital</name>
        <address>
          <city>Oslo</city>
          <zip>0586</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lars Ø Høiseth, PhD</last_name>
        <email>LHOIS@ous-hf.no</email>
      </contact>
      <investigator>
        <last_name>Lars Ø Høiseth, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hydration</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Water Intoxication</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/NCT06003205
  org study id: DOC1040A COBI
  nct id: NCT06003205
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an exploratory interventional study. The aim of the investigation is to identify and
        quantify contributing factors to local bioimpedance spectroscopy (BIS) measured by a wearable
        sensor patch, particularly the effect of fluid shifts caused by postural changes and lower
        body negative pressure (LBNP).
  The investigational devices (patches) will perform near-continuous measurements of
        multifrequency bioimpedance (BIS), temperature, and body orientation (accelerometer) during
        the entire period of wear (2 days). Patches will be mounted at the upper body (back and
        thorax) and calf. The primary objective is to assess the effect of prolonged lower body
        negative pressure (LBNP) on the BIS of the calf. The target population is healthy volunteers
        between 18-50 years old.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Relative change in extracellular resistance of the calf from t0 to t1 (immediately before and after 40 minutes of LBNP at 30 mmHg), measured by the investigational bioimpedance device
  time frame: 40 minutes
  description: Relative change in extracellular resistance at the calf from before to after 40 minutes of lower body negative pressure, to assess the effect of prolonged LBNP.
  measure: Change in extracellular resistance at the upper back following postural changes, measured by the investigational bioimpedance device.
  time frame: 6 hours
  description: Relative change in extracellular resistance at the upper back following changes in posture
  measure: Changes in extracellular resistance at the upper back following application of three different external pressures.
  time frame: 2 hours
  description: Mean differences in extracellular resistance of the upper back, when the subject lays in a supine position on three different surfaces. Extracellular resistance is measured by the investigational bioimpedance device.
  measure: Frequency and severity of adverse device effects
  time frame: 3 days
  description: To assess the safety of the investigational device in healthy volunteers
  arm group label: Wearable bioimpedance sensor
  arm group type: Other
  description: All subjects will use the investigational device and undergo several interventions: lower body negative pressure (3-40 minutes at 30 mmHg), posture intervention, and pressure intervention.
  intervention type: Device
  intervention name: Wearable bioimpedance sensor
  description: The investigational device is an electronic bioimpedance-based, body-worn, battery-powered sensor intended to monitor changes in fluid volume. It is designed as an adhesive patch with four integrated electrodes.
  arm group label: Wearable bioimpedance sensor
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sigve N Aas, PhD
  role: Study Director
  affiliation: Mode Sensors AS
  last name: Lars Ø Høiseth, PhD
  role: Principal Investigator
  affiliation: Oslo University Hospital
  last name: Sigve N Aas, PhD
  phone: 004741499074
  email: sigve.aas@modesensors.com
  last name: Frida Bremnes, M.Sc.
  email: frida.bremnes@modesensors.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Norway
  responsible party type: Sponsor
  mesh term: Water Intoxication
  sharing ipd: No