<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/NCT04451824</url>
  </required_header>
  <id_info>
    <org_study_id>CL100 CR RetrX1</org_study_id>
    <nct_id>NCT04451824</nct_id>
  </id_info>
  <brief_title>Examination of Circumferential Reduction</brief_title>
  <official_title>Contour Research CL-100 Examination of Circumferential Reduction: A Review of Data Collected From Routine Use of the Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Contour Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Contour Research</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 rationale for the selection of Outcome Measures is the compliance with FDA regulations as&#xD;
      pertain to medical devices with a moderate level of risk of hazard leading to harm of the&#xD;
      patient; firstly, the safety of the device in achieving the desired effect of its intended&#xD;
      use when operated in the intended manner; and secondly, the effectiveness of the device in&#xD;
      achieving its desired effect of its intended use in accordance with its proposed label and&#xD;
      labeling. The rationale for the selection of the primary outcome measure is to satisfy the&#xD;
      question of safety and effectiveness of the use of red-light exposure to reduce the&#xD;
      circumference of overweight patients with a statistically significant Routine Use population&#xD;
      size. Given that the Routine Use Data Analysis is open label and therefore not blinded, there&#xD;
      is no need for a control group nor additional cohorts for varying levels of exposure and&#xD;
      corresponding safety and/or effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the 1960s, the concept of using light energy for a variety of health maintenance goals and&#xD;
      overcoming a number of dermatological conditions began in earnest to receive the attention of&#xD;
      NASA researchers as a means of providing desired clinical outcomes to astronauts while in the&#xD;
      confines of a space capsule over long periods of time. The research was well funded and&#xD;
      supported by the U.S. government, and confirmed the value of light emitting diode (LED)&#xD;
      low-level light therapy (LLLT), in particular red light from the 635nm frequency, for&#xD;
      producing a variety of healthful effects within the dermis. The ability to achieve a&#xD;
      reduction in the dimensions of exposed liposomes using red light is intended to be confirmed&#xD;
      by analyzing the clinical data from a minimum of one hundred patients who were exposed to the&#xD;
      635 nm frequency for 30 minutes by use of the subject device (Contour Light) during routine&#xD;
      use to confirm that the device is safe and effective for its intended application. Please see&#xD;
      the following clinical articles, appended in section 10.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 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>
    <intervention_model_description>Routine use of device</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Examination of Circumferential Reduction - Primary Objective</measure>
    <time_frame>&lt;1 hour</time_frame>
    <description>To confirm the proper use of the device induces a change in the circumference of the patients thighs, hips and waist, when exposed to the red light (635nm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examination of Circumferential Reduction - Secondary Objective</measure>
    <time_frame>&lt;1 hour</time_frame>
    <description>To achieve a contour change, specifically a lessening of the protrusion of body fat, when exposed to the red light (635nm)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Overweight or Obesity</condition>
  <arm_group>
    <arm_group_label>Intervention with Routine Use of Red Light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Routine Use of red light (635nm) for 30 minutes on patients is to be observed in relation to its effect(s) in achieving circumferential reduction of the thighs, hips and waist of the patient, and a contour reduction of any protrusion of fat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CL-100</intervention_name>
    <description>Red Light LED device for circumferential reduction</description>
    <arm_group_label>Intervention with Routine Use of Red Light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and Females ages 18 and above&#xD;
&#xD;
          -  Generally good health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active cancer within the past year&#xD;
&#xD;
          -  Pacemaker&#xD;
&#xD;
          -  Diminished ability to void waste (liver and/or kidney function impairment)&#xD;
&#xD;
          -  Photosensitivity (generally and/or from medication)&#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>Doug Dreier, BS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Contour Research, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gibson Clinic</name>
      <address>
        <city>Vista</city>
        <state>California</state>
        <zip>92083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barone Clinic</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Love Clinic</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share the individual participant data with other researchers.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>August 27, 2021</submitted>
    <returned>September 22, 2021</returned>
  </pending_results>
  <!-- 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/NCT04451824
org study id: CL100 CR RetrX1
nct id: NCT04451824
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The rationale for the selection of Outcome Measures is the compliance with FDA regulations as
      pertain to medical devices with a moderate level of risk of hazard leading to harm of the
      patient; firstly, the safety of the device in achieving the desired effect of its intended
      use when operated in the intended manner; and secondly, the effectiveness of the device in
      achieving its desired effect of its intended use in accordance with its proposed label and
      labeling. The rationale for the selection of the primary outcome measure is to satisfy the
      question of safety and effectiveness of the use of red-light exposure to reduce the
      circumference of overweight patients with a statistically significant Routine Use population
      size. Given that the Routine Use Data Analysis is open label and therefore not blinded, there
      is no need for a control group nor additional cohorts for varying levels of exposure and
      corresponding safety and/or effectiveness.
In the 1960s, the concept of using light energy for a variety of health maintenance goals and
      overcoming a number of dermatological conditions began in earnest to receive the attention of
      NASA researchers as a means of providing desired clinical outcomes to astronauts while in the
      confines of a space capsule over long periods of time. The research was well funded and
      supported by the U.S. government, and confirmed the value of light emitting diode (LED)
      low-level light therapy (LLLT), in particular red light from the 635nm frequency, for
      producing a variety of healthful effects within the dermis. The ability to achieve a
      reduction in the dimensions of exposed liposomes using red light is intended to be confirmed
      by analyzing the clinical data from a minimum of one hundred patients who were exposed to the
      635 nm frequency for 30 minutes by use of the subject device (Contour Light) during routine
      use to confirm that the device is safe and effective for its intended application. Please see
      the following clinical articles, appended in section 10.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Routine use of device
primary purpose: Treatment
masking: None (Open Label)
measure: Examination of Circumferential Reduction - Primary Objective
time frame: <1 hour
description: To confirm the proper use of the device induces a change in the circumference of the patients thighs, hips and waist, when exposed to the red light (635nm)
measure: Examination of Circumferential Reduction - Secondary Objective
time frame: <1 hour
description: To achieve a contour change, specifically a lessening of the protrusion of body fat, when exposed to the red light (635nm)
arm group label: Intervention with Routine Use of Red Light
arm group type: Experimental
description: Routine Use of red light (635nm) for 30 minutes on patients is to be observed in relation to its effect(s) in achieving circumferential reduction of the thighs, hips and waist of the patient, and a contour reduction of any protrusion of fat.
intervention type: Device
intervention name: CL-100
description: Red Light LED device for circumferential reduction
arm group label: Intervention with Routine Use of Red Light
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Doug Dreier, BS
role: Principal Investigator
affiliation: Contour Research, LLC
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No
ipd description: There is no plan to share the individual participant data with other researchers.
submitted: August 27, 2021
returned: September 22, 2021