<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/NCT03240926</url>
  </required_header>
  <id_info>
    <org_study_id>32315</org_study_id>
    <nct_id>NCT03240926</nct_id>
  </id_info>
  <brief_title>Loop Band Validation Study</brief_title>
  <official_title>Loop Band Validation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spry Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spry Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to assess the accuracy of a non-invasive wearable&#xD;
      technology in the form of a wristband.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of this study is to assess the accuracy of a non-invasive wearable&#xD;
      technology in the form of a wristband. This wristband (Loop Band) uses optical sensors and&#xD;
      spectrometry to measure and estimate vitals as well as a full blood gas panel; comparable to&#xD;
      the standard method of an invasive arterial line and pressure transducer. The investigators&#xD;
      aim to show equivalence of clinical physiologic outcome measurements with the Loop Band&#xD;
      relative to current methods (i.e. arterial lines, etc.). In addition, this study aims to&#xD;
      validate this wearable technology as a potential alternative to invasive measurements, to&#xD;
      reduce complications, and improve accuracy in regards to patient monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">January 25, 2018</completion_date>
  <primary_completion_date type="Actual">January 22, 2018</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate) measured by Arterial Line.</measure>
    <time_frame>intraoperative</time_frame>
    <description>Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate etc.) with the Loop Band relative to current methods (i.e. arterial lines, etc.) during a surgical procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>intraoperative</time_frame>
    <description>Evaluate safety data based on reported Adverse Events (AEs).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">235</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Loop Band</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Measure accuracy of vital sign measurements</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Loop Band</intervention_name>
    <description>Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line.</description>
    <arm_group_label>Loop Band</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has capacity to consent for the study.&#xD;
&#xD;
          -  Anesthetic plan for an arterial line for vital sign monitoring during their surgical&#xD;
             procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active Atrial Fibrillation&#xD;
&#xD;
          -  Active C-difficile&#xD;
&#xD;
          -  Amputation of the arm at the wrist or above&#xD;
&#xD;
          -  The Investigator and/or Clinical Research Nurse will conduct a visual inspection for&#xD;
             attributes that may diminish device accuracy. These include but are not limited to:&#xD;
             tattoos over the radial artery, burns or heavy scarring over the radial artery,&#xD;
             fragile skin, any skin diseases affecting the wrist or arm, Physician discretion-any&#xD;
             condition deemed inappropriate that will preclude use of the device.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harry Bowles, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spry Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Huntington Memorial Hospital</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>June 14, 2018</last_update_submitted>
  <last_update_submitted_qc>June 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>COPD Exacerbation</keyword>
  <keyword>COPD Asthma</keyword>
  <keyword>COPD Bronchitis</keyword>
  <keyword>COPD, Severe Early-Onset</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/NCT03240926
org study id: 32315
nct id: NCT03240926
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The main purpose of this study is to assess the accuracy of a non-invasive wearable
      technology in the form of a wristband.
The main purpose of this study is to assess the accuracy of a non-invasive wearable
      technology in the form of a wristband. This wristband (Loop Band) uses optical sensors and
      spectrometry to measure and estimate vitals as well as a full blood gas panel; comparable to
      the standard method of an invasive arterial line and pressure transducer. The investigators
      aim to show equivalence of clinical physiologic outcome measurements with the Loop Band
      relative to current methods (i.e. arterial lines, etc.). In addition, this study aims to
      validate this wearable technology as a potential alternative to invasive measurements, to
      reduce complications, and improve accuracy in regards to patient monitoring.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Device Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate) measured by Arterial Line.
time frame: intraoperative
description: Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate etc.) with the Loop Band relative to current methods (i.e. arterial lines, etc.) during a surgical procedure.
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: intraoperative
description: Evaluate safety data based on reported Adverse Events (AEs).
arm group label: Loop Band
arm group type: Experimental
description: Measure accuracy of vital sign measurements
intervention type: Device
intervention name: Loop Band
description: Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line.
arm group label: Loop Band
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Harry Bowles, MD
role: Principal Investigator
affiliation: Spry Health
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No