<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/NCT02187237</url>
  </required_header>
  <id_info>
    <org_study_id>YTCSP-2013-YOLO-REDUCE</org_study_id>
    <nct_id>NCT02187237</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of the &quot;YOLO TOUCH&quot; LLLT for Circumference Reduction of the Waistline</brief_title>
  <acronym>REDUCE</acronym>
  <official_title>A RandomizEd DoUble Blinded Controlled Study to Evaluate the Safety and Effectiveness of the &quot;YOLO TOUCH&quot; Low Level Laser Therapy (LLLT) for Circumference Reduction of he Waistline - REDUCE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yolo Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yolo Medical Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The YOLO TOUCH consists of a console and multi-probes that are placed on the treatment area&#xD;
      that emit laser light to reduce the circumference waistline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The YOLO TOUCH device is class II device intended for use in circumference reduction of the&#xD;
      waist as a non-invasive, non-thermal, and low energy laser. Typical area of the body for use&#xD;
      with the YOLO TOUCH is the abdominal area.&#xD;
&#xD;
      The YOLO TOUCH low-level therapy device consists of a main console and 8 multi-probes that&#xD;
      are constructed so that each probe contains 12 laser emission diode sources at a power output&#xD;
      of 35mW per diode.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of girth measurements for the waistline</measure>
    <time_frame>3 weeks</time_frame>
    <description>Reduction of one (1.0) inch of girth measurement in the average of three circumference measurements for the waistline from baseline to after completion of the three (3) week study procedure (i.e., after nine (9) twenty (20) minute laser treatments - three (3) per week for three (3) weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications, device related adverse events during LLLT and device related adverse events post LLLT.</measure>
    <time_frame>up to at day 50</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Reduction of the Waist Circumference</condition>
  <arm_group>
    <arm_group_label>Laser therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>YOLO TOUCH Low Level Laser</intervention_name>
    <arm_group_label>Laser therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is an adult ≥ 18 years old and &lt;65 years of age&#xD;
&#xD;
          -  Subject has maintained a stable weight for the past 6 months (variation no greater&#xD;
             than 10 lbs. from &quot;usual weight&quot;)&#xD;
&#xD;
          -  Subject is willing to maintain current diet and exercise regimen for the duration of&#xD;
             the study.&#xD;
&#xD;
          -  Subject is willing and able to provide written informed consent.&#xD;
&#xD;
          -  Subject is willing to return for all scheduled and required visits.&#xD;
&#xD;
          -  Subject is willing to comply with post-laser treatment cardiovascular exercise.&#xD;
&#xD;
          -  Subject is willing to comply with food and fluid requirements pre-treatment and&#xD;
             post-treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is on an active weight control regimen.&#xD;
&#xD;
          -  Subject has a pacemaker.&#xD;
&#xD;
          -  Subject has a history of epilepsy.&#xD;
&#xD;
          -  Subject has a history of any type of cancer, including skin cancer.&#xD;
&#xD;
          -  Subject had a prior surgical intervention for body sculpting/weight loss such as&#xD;
             liposuction, abdominoplasty, gastroplasty, lap band surgery, etc.&#xD;
&#xD;
          -  Subject has a medical, physical, or other contraindications for body sculpting/weight&#xD;
             loss.&#xD;
&#xD;
          -  Subject has an active infection, wound or other external trauma to the areas to be&#xD;
             treated with the laser.&#xD;
&#xD;
          -  Subject is pregnant, breast feeding, or planning pregnancy prior to study end.&#xD;
&#xD;
          -  Subject is participating in any treatment other than the study procedure (existing or&#xD;
             new) to promote body contouring and/or weight loss during the course o the study&#xD;
             participation.&#xD;
&#xD;
          -  Subject is participating in another research study of a device, medication, biologic,&#xD;
             or other agent within 30 days or could, in the opinion of the investigator, affect the&#xD;
             results of this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Portz, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Burnett Sports Perfomance Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Burnett Sports Performance Center</name>
      <address>
        <city>McMurray</city>
        <state>Pennsylvania</state>
        <zip>15317</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <pending_results>
    <submitted>February 7, 2017</submitted>
    <returned>March 27, 2017</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/NCT02187237
org study id: YTCSP-2013-YOLO-REDUCE
nct id: NCT02187237
lead sponsor: 
has dmc: Yes
The YOLO TOUCH consists of a console and multi-probes that are placed on the treatment area
      that emit laser light to reduce the circumference waistline.
The YOLO TOUCH device is class II device intended for use in circumference reduction of the
      waist as a non-invasive, non-thermal, and low energy laser. Typical area of the body for use
      with the YOLO TOUCH is the abdominal area.

      The YOLO TOUCH low-level therapy device consists of a main console and 8 multi-probes that
      are constructed so that each probe contains 12 laser emission diode sources at a power output
      of 35mW per diode.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Reduction of girth measurements for the waistline
time frame: 3 weeks
description: Reduction of one (1.0) inch of girth measurement in the average of three circumference measurements for the waistline from baseline to after completion of the three (3) week study procedure (i.e., after nine (9) twenty (20) minute laser treatments - three (3) per week for three (3) weeks.
measure: Complications, device related adverse events during LLLT and device related adverse events post LLLT.
time frame: up to at day 50
arm group label: Laser therapy
arm group type: Experimental
intervention type: Device
intervention name: YOLO TOUCH Low Level Laser
arm group label: Laser therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Matthew Portz, M.D.
role: Principal Investigator
affiliation: Burnett Sports Perfomance Center
facility: 
country: United States
responsible party type: Sponsor
submitted: February 7, 2017
returned: March 27, 2017