<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/NCT03810833</url>
  </required_header>
  <id_info>
    <org_study_id>ORFM Sensor 100-01</org_study_id>
    <nct_id>NCT03810833</nct_id>
  </id_info>
  <brief_title>Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System</brief_title>
  <official_title>A Study of Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MediBeacon</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MediBeacon</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate background fluorescence of participants of different ages,&#xD;
      gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MediBeacon Transdermal GFR Measurement System investigational is intended to measure the&#xD;
      Glomerular Filtration Rate (GFR) in patients with normal or impaired renal function by&#xD;
      noninvasively monitoring fluorescent light emission from an exogenous tracer agent (MB-102)&#xD;
      over time. The device utilized in this study is the Brilliance device. Approximately 1 male&#xD;
      and 1 female from each age cohort (18-50 years; 51+ years) and clustered Fitzpatrick Skin&#xD;
      Scale groups (I-II [Light, pale white; white, fair]; III-IV [Medium, white to olive; olive,&#xD;
      moderate brown]; and V-VI [Brown, dark brown; black, very dark brown to black]) will be&#xD;
      recruited, for a total of 12 participants. Participants will have Brilliance device sensors&#xD;
      placed on two locations on their skin, which will remain for 48 hours. The sensor location&#xD;
      will be prepared through shaving and cleaning (as applicable), placed on the skin via&#xD;
      standard single-use adhesive pads, and baseline measurements collected. Participants may&#xD;
      undergo activities of daily living while measurements are being collected. Light pressure and&#xD;
      other minor perturbations may be applied to the sensors to evaluate the effect on background&#xD;
      fluorescence. Adverse events associated with sensor placement (such as skin irritations) will&#xD;
      be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2019</start_date>
  <completion_date type="Actual">September 23, 2019</completion_date>
  <primary_completion_date type="Actual">September 23, 2019</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>Mean Background Fluorescence</measure>
    <time_frame>From the time of sensor placement to 48 hours after placement</time_frame>
    <description>Two separate Brilliance device sensors will be attached via standard adhesive pads to the left and right pectoralis major on each participant. Fluorescence measurements will be collected directly by the MediBeacon Transdermal GFR Measurement System Brilliance device, and will be continuously collected throughout the 48 hour study.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Participants with Brilliance sensor placement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brilliance device sensors placed on the left and right pectoralis major, remaining for 48 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Brilliance device sensor</intervention_name>
    <description>Two separate sensors will be attached via standard, single-use adhesive pads to the left and right pectoralis major on each participant.</description>
    <arm_group_label>Participants with Brilliance sensor placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female adults age 18 and older&#xD;
&#xD;
          -  2 age cohorts to be recruited: 18 - 50 years of age and 51+ years or older&#xD;
&#xD;
          -  Skin color groups to be recruited in accordance with the Fitzpatrick Skin Scale (I -&#xD;
             VI)&#xD;
&#xD;
          -  Participants willing to sign the Institutional Review Board (IRB) approved informed&#xD;
             consent form prior to the initiation of any study specific procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)&#xD;
&#xD;
          -  Any characteristics which, in the opinion of the investigator, makes the participant a&#xD;
             poor candidate for participation in the clinical trial&#xD;
&#xD;
          -  Significant scarring, tattoos or alterations in pigmentation on the standardized&#xD;
             sensor locations that would alter sensor readings versus other areas of the skin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard B Dorshow, PhD</last_name>
    <role>Study Director</role>
    <affiliation>MediBeacon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Louis Clinical Trials</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glomerular Filtration Rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <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/NCT03810833
org study id: ORFM Sensor 100-01
nct id: NCT03810833
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
This study is designed to evaluate background fluorescence of participants of different ages,
      gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be
      evaluated.
The MediBeacon Transdermal GFR Measurement System investigational is intended to measure the
      Glomerular Filtration Rate (GFR) in patients with normal or impaired renal function by
      noninvasively monitoring fluorescent light emission from an exogenous tracer agent (MB-102)
      over time. The device utilized in this study is the Brilliance device. Approximately 1 male
      and 1 female from each age cohort (18-50 years; 51+ years) and clustered Fitzpatrick Skin
      Scale groups (I-II [Light, pale white; white, fair]; III-IV [Medium, white to olive; olive,
      moderate brown]; and V-VI [Brown, dark brown; black, very dark brown to black]) will be
      recruited, for a total of 12 participants. Participants will have Brilliance device sensors
      placed on two locations on their skin, which will remain for 48 hours. The sensor location
      will be prepared through shaving and cleaning (as applicable), placed on the skin via
      standard single-use adhesive pads, and baseline measurements collected. Participants may
      undergo activities of daily living while measurements are being collected. Light pressure and
      other minor perturbations may be applied to the sensors to evaluate the effect on background
      fluorescence. Adverse events associated with sensor placement (such as skin irritations) will
      be recorded.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Mean Background Fluorescence
time frame: From the time of sensor placement to 48 hours after placement
description: Two separate Brilliance device sensors will be attached via standard adhesive pads to the left and right pectoralis major on each participant. Fluorescence measurements will be collected directly by the MediBeacon Transdermal GFR Measurement System Brilliance device, and will be continuously collected throughout the 48 hour study.
arm group label: Participants with Brilliance sensor placement
arm group type: Experimental
description: Brilliance device sensors placed on the left and right pectoralis major, remaining for 48 hours
intervention type: Device
intervention name: Brilliance device sensor
description: Two separate sensors will be attached via standard, single-use adhesive pads to the left and right pectoralis major on each participant.
arm group label: Participants with Brilliance sensor placement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard B Dorshow, PhD
role: Study Director
affiliation: MediBeacon
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Kidney Injury
sharing ipd: No