<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/NCT03242564</url>
  </required_header>
  <id_info>
    <org_study_id>Vev-2017-1</org_study_id>
    <nct_id>NCT03242564</nct_id>
  </id_info>
  <brief_title>Effects of Red Light LED Therapy on Body Contouring</brief_title>
  <official_title>A Retrospective Analysis of the Effects of Red Light LED Therapy on Body Contouring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vevazz, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vevazz, LLC</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_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether red light therapy using LED 650nm red light&#xD;
      for body contouring of the waist, hips and thighs is as effective as red light therapy using&#xD;
      Laser 635nm red light.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Red light laser therapy using 635nm red light laser technology has previously been shown to&#xD;
      cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body&#xD;
      contouring. This study hypothesizes that red LED light therapy using 650nm red light LED&#xD;
      (light emitting diode) technology produces similar results to the laser device (red LASER&#xD;
      635nm) when preformed using a specified treatment protocol.&#xD;
&#xD;
      Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after a&#xD;
      single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward&#xD;
      Photonics) achieves its results after one 32 minute therapy program.&#xD;
&#xD;
      The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light&#xD;
      therapy. This multi-site study reviews results from 66 randomly selected patients after a&#xD;
      single treatment using the Vevazz LED device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Actual">July 21, 2017</completion_date>
  <primary_completion_date type="Actual">July 21, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost</measure>
    <time_frame>One 28 minute treatment session.</time_frame>
    <description>Circumferential measurement of thighs, hips and waist before and after treatment.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Active Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active Device: Vevazz LED red light therapy system&#xD;
Vevazz LED red light therapy system is a treatment regimen using the Vevazz LED device for fat removal using LED red light therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vevazz LED</intervention_name>
    <description>Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.</description>
    <arm_group_label>Active Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years or older.&#xD;
&#xD;
          -  May be male or female.&#xD;
&#xD;
          -  Generally good health.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors.&#xD;
&#xD;
          -  Open wounds or sores.&#xD;
&#xD;
          -  Pacemaker.&#xD;
&#xD;
          -  Photosensitivity.&#xD;
&#xD;
          -  Epilepsy.&#xD;
&#xD;
          -  Any form of cancer.&#xD;
&#xD;
          -  Severe kidney or liver problems.&#xD;
&#xD;
          -  Thyroid problems.&#xD;
&#xD;
          -  Pregnant or nursing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>77 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jamie Fettig</last_name>
    <role>Study Director</role>
    <affiliation>Owner</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vevazz, LLC</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No current plan to share data.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>December 15, 2017</submitted>
    <returned>January 12, 2018</returned>
    <submitted>July 3, 2018</submitted>
    <returned>July 30, 2018</returned>
    <submitted>August 7, 2018</submitted>
    <returned>September 6, 2018</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/NCT03242564
org study id: Vev-2017-1
nct id: NCT03242564
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to determine whether red light therapy using LED 650nm red light
      for body contouring of the waist, hips and thighs is as effective as red light therapy using
      Laser 635nm red light.
Red light laser therapy using 635nm red light laser technology has previously been shown to
      cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body
      contouring. This study hypothesizes that red LED light therapy using 650nm red light LED
      (light emitting diode) technology produces similar results to the laser device (red LASER
      635nm) when preformed using a specified treatment protocol.

      Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after a
      single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward
      Photonics) achieves its results after one 32 minute therapy program.

      The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light
      therapy. This multi-site study reviews results from 66 randomly selected patients after a
      single treatment using the Vevazz LED device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost
time frame: One 28 minute treatment session.
description: Circumferential measurement of thighs, hips and waist before and after treatment.
arm group label: Active Device
arm group type: Experimental
description: Active Device: Vevazz LED red light therapy system
Vevazz LED red light therapy system is a treatment regimen using the Vevazz LED device for fat removal using LED red light therapy.
intervention type: Device
intervention name: Vevazz LED
description: Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.
arm group label: Active Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 77 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jamie Fettig
role: Study Director
affiliation: Owner
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: No current plan to share data.
submitted: December 15, 2017
returned: January 12, 2018
submitted: July 3, 2018
returned: July 30, 2018
submitted: August 7, 2018
returned: September 6, 2018