<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/NCT04461834</url>
  </required_header>
  <id_info>
    <org_study_id>RIVA_Basel</org_study_id>
    <nct_id>NCT04461834</nct_id>
  </id_info>
  <brief_title>Accuracy of the RIVA Digital Blood Pressure Measurement App - a Pilot Study</brief_title>
  <official_title>Accuracy of the RIVA Digital Blood Pressure Measurement App After Initial Calibration and After 24 Hours in a General Population - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement</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 aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure&#xD;
      Measurement App with and without initial calibration. Additionally, accuracy of the Blood&#xD;
      Pressure Measurement 24 hours after calibration will also be tested.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Conventional blood pressure measurements (BPM) using a cuff-based device are actually gold&#xD;
      standard of BPM in clinical practice. Due to availability and patient comfort, the number of&#xD;
      such BPM is limited. Considering the large number of people using smartphones, app-based&#xD;
      measurements and screening procedures have the potential to increase the availability of BPM&#xD;
      and improve blood pressure control, but a prerequisite of the use of these alternative BPM&#xD;
      methods is accuracy.&#xD;
&#xD;
      The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure&#xD;
      Measurement App with and without initial calibration. Additionally, accuracy of the BPM 24&#xD;
      hours after calibration will also be tested.&#xD;
&#xD;
      Before mounting the 24h-Blood Pressure (BP) monitor, a set of 11 BPM will be taken, starting&#xD;
      with a conventional BPM using a Welch Allyn Connex® Spot Monitor, then alternating to the&#xD;
      app, leading to 6 possible pairs of comparison. The next day, without another calibration of&#xD;
      the app, we will take another 3 pairs of comparison (7 alternating measurements, starting&#xD;
      with a conventional measurement). Examinators are blinded for the results of the app&#xD;
      measurements. The app automatically sends the data of the BPM to RIVA Digital, where the&#xD;
      results measured by the app will be processed. The staff of RIVA Digital are blinded to the&#xD;
      conventional BPM results.&#xD;
&#xD;
      Number of Participants: 50 consecutive patients will be included in the study.&#xD;
&#xD;
      Statistical analyses: Both BPM procedures are analyzed for correlation and accuracy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">September 24, 2020</completion_date>
  <primary_completion_date type="Actual">September 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Data statistical analysis</measure>
    <time_frame>1 year</time_frame>
    <description>Both Blood Pressure Measurement procedures are analysed for correlation and accuracy</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Blood Pressure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        AIl patients undergoing a 24h-ambulatory blood pressure measurement are eligible.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing a 24h-ambulatory blood pressure measurement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  impossibility to sign informed consent&#xD;
&#xD;
          -  physical restrictions to Blood Pressure Measurement&#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>Michael Mayr, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 29, 2020</last_update_submitted>
  <last_update_submitted_qc>September 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood Pressure</keyword>
  <keyword>RIVA</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04461834
org study id: RIVA_Basel
nct id: NCT04461834
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure
      Measurement App with and without initial calibration. Additionally, accuracy of the Blood
      Pressure Measurement 24 hours after calibration will also be tested.
Conventional blood pressure measurements (BPM) using a cuff-based device are actually gold
      standard of BPM in clinical practice. Due to availability and patient comfort, the number of
      such BPM is limited. Considering the large number of people using smartphones, app-based
      measurements and screening procedures have the potential to increase the availability of BPM
      and improve blood pressure control, but a prerequisite of the use of these alternative BPM
      methods is accuracy.

      The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure
      Measurement App with and without initial calibration. Additionally, accuracy of the BPM 24
      hours after calibration will also be tested.

      Before mounting the 24h-Blood Pressure (BP) monitor, a set of 11 BPM will be taken, starting
      with a conventional BPM using a Welch Allyn Connex® Spot Monitor, then alternating to the
      app, leading to 6 possible pairs of comparison. The next day, without another calibration of
      the app, we will take another 3 pairs of comparison (7 alternating measurements, starting
      with a conventional measurement). Examinators are blinded for the results of the app
      measurements. The app automatically sends the data of the BPM to RIVA Digital, where the
      results measured by the app will be processed. The staff of RIVA Digital are blinded to the
      conventional BPM results.

      Number of Participants: 50 consecutive patients will be included in the study.

      Statistical analyses: Both BPM procedures are analyzed for correlation and accuracy.
observational model: Cohort
time perspective: Cross-Sectional
measure: Data statistical analysis
time frame: 1 year
description: Both Blood Pressure Measurement procedures are analysed for correlation and accuracy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Mayr, PD Dr.
role: Principal Investigator
affiliation: University Hospital of Basel
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No