<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/NCT03805815</url>
  </required_header>
  <id_info>
    <org_study_id>H-1808-177-969</org_study_id>
    <nct_id>NCT03805815</nct_id>
  </id_info>
  <brief_title>Clinical Implication of the Tunable Crack Sensor</brief_title>
  <official_title>Development of Diagnosis Algorism for Paroxysmal Arrhythmia Using Ultra-thin Resistive Membrane: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      [Development of diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive&#xD;
      membrane: a pilot study] Comparison of blood pressure via tunable crack sensor and invasive&#xD;
      pressure wire&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To develop a diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive&#xD;
      membrane, we will compare the blood pressure measured via a tunable crack sensor and that&#xD;
      measured by a invasive pressure wire&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 10, 2018</start_date>
  <completion_date type="Anticipated">August 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure monitoring using tunable crack sensor</measure>
    <time_frame>immediately</time_frame>
    <description>Systolic blood pressure and diastolic blood pressure by using tunable crack sensor</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Blood Pressure</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tunable crack sensor</intervention_name>
    <description>blood pressure monitoring via crack sensor</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A case of suspected coronary artery disease for the purpose of coronary angiography&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A case of suspected coronary artery disease at Seoul National University Hospital for the&#xD;
        purpose of coronary angiography&#xD;
&#xD;
          -  At least 19 years old&#xD;
&#xD;
          -  If he/she hears enough explanation about clinical research and intends to participate&#xD;
             in clinical research himself&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 19 years old&#xD;
&#xD;
          -  Refusal to participate in clinical studies&#xD;
&#xD;
          -  If the cognitive function is weak enough not to understand the explanation of the&#xD;
             clinical study and to make voluntary decisions accordingly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bon-Kwon Koo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul national university hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Kang D, Pikhitsa PV, Choi YW, Lee C, Shin SS, Piao L, Park B, Suh KY, Kim TI, Choi M. Ultrasensitive mechanical crack-based sensor inspired by the spider sensory system. Nature. 2014 Dec 11;516(7530):222-6. doi: 10.1038/nature14002.</citation>
    <PMID>25503234</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Bon-Kwon Koo</investigator_full_name>
    <investigator_title>Professor of Medicine / Cardiology</investigator_title>
  </responsible_party>
  <keyword>blood pressure</keyword>
  <keyword>crack sensor</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03805815
org study id: H-1808-177-969
nct id: NCT03805815
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
[Development of diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive
      membrane: a pilot study] Comparison of blood pressure via tunable crack sensor and invasive
      pressure wire
To develop a diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive
      membrane, we will compare the blood pressure measured via a tunable crack sensor and that
      measured by a invasive pressure wire
observational model: Cohort
time perspective: Prospective
measure: Blood pressure monitoring using tunable crack sensor
time frame: immediately
description: Systolic blood pressure and diastolic blood pressure by using tunable crack sensor
intervention type: Device
intervention name: tunable crack sensor
description: blood pressure monitoring via crack sensor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bon-Kwon Koo
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Kang D, Pikhitsa PV, Choi YW, Lee C, Shin SS, Piao L, Park B, Suh KY, Kim TI, Choi M. Ultrasensitive mechanical crack-based sensor inspired by the spider sensory system. Nature. 2014 Dec 11;516(7530):222-6. doi: 10.1038/nature14002.
PMID: 25503234
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Bon-Kwon Koo
investigator title: Professor of Medicine / Cardiology
sharing ipd: Undecided