<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/NCT03811093</url>
  </required_header>
  <id_info>
    <org_study_id>invisa-RED_Trial</org_study_id>
    <nct_id>NCT03811093</nct_id>
  </id_info>
  <brief_title>Comparing the Efficacy of a Dual-Frequency LLLT Device With a Sham Device as a Therapy for Adipose Tissue Loss</brief_title>
  <official_title>Comparing the Efficacy of a Dual-Frequency Laser-Emitting Device, the &quot;Invisared-RED Elite&quot;, With a Sham Device as Therapy for the Loss of Adipose Tissue (Body Fat) and Aesthetics in Overweight Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IR Technology, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IR Technology, 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 trial was designed to provide empirical evidence with which to compare the efficacy and&#xD;
      safety of the invisa-RED Technology Elite Low-level Laser Therapy (LLLT) device with a sham&#xD;
      device as a placebo, when both are used in the treatment of individuals to reduce body fat&#xD;
      and improve body aesthetics. At the conclusion of the trial; the change in body fat&#xD;
      percentage, the change in total body fat in pounds, and total inches lost of the two groups&#xD;
      were statistically analyzed to determine the efficacy of the invisa-RED Technology Elite when&#xD;
      used for body fat (adipose tissue) loss and/or aesthetics therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial was designed to prove the efficacy and safety of the invisa-RED Technology Elite&#xD;
      Low-level Laser Therapy (LLLT) device. The trial compared results between two groups; the&#xD;
      first group was treated using a fully functional invisa-RED Technology Elite device; this&#xD;
      group was designated the Usual Care Group.&#xD;
&#xD;
      The second, a control group, was treated utilizing a nonfunctional invisa-RED Technology&#xD;
      Elite device; this group is referred to as the Sham Group.The sham device consisted of an&#xD;
      invisa-RED Technology Elite device that will appear to operate as the Usual Care Group device&#xD;
      to the operator and participants, but the laser diodes will be disabled and will receive no&#xD;
      power providing a placebo effect. If staff or a participant questions the efficacy of the&#xD;
      sham device, an assertion may be made that only a near infrared, non-visible frequency of&#xD;
      light, is being employed.&#xD;
&#xD;
      The trial was conducted employing a double blind study methodology; participants were&#xD;
      randomly assigned to each group through a drawing, neither participants nor clinicians knew&#xD;
      to which trial group they were assigned. To ensure the double blind; treatment for the two&#xD;
      groups occurred separately using clinicians exclusive to each group.&#xD;
&#xD;
      A simplified weight loss protocol was employed based on the &quot;Consultation Protocol&quot; from the&#xD;
      invisa-Red Training Manual. All study participants received nine (9) therapy sessions of 20&#xD;
      minutes each; power settings were based on the participants Fitzpatrick Scale skin type. For&#xD;
      skin types i and ii a power setting of 7 was used, for skin types iii and iv a power setting&#xD;
      of 6, for skin types v and vi a power setting of 4 was employed. At the conclusion of the&#xD;
      nine (9) therapy sessions; the change in weight of body fat, body fat as a percentage of&#xD;
      total body weight, and inches lost of the two groups were statistically analyzed to determine&#xD;
      the efficacy of the invisa-RED Technology Elite as a therapy to reduce adipose tissue. The&#xD;
      occurrence of any medical errors were documented and included in the statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">February 9, 2019</completion_date>
  <primary_completion_date type="Actual">February 9, 2019</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>Parallel Assignment</intervention_model>
    <intervention_model_description>The trial compared results between two groups of participants; the first group was treated using a fully functional device. The second, a control group, was treated utilizing a nonfunctional device. At the conclusion of nine (9) therapy sessions; the change in body fat percentage, the change in body fat in pounds, and inches lost of the two groups will be statistically analyzed to determine the efficacy of the invisa-RED Technology Elite as a weight loss therapy. Any medical errors will be included in the statistical analysis.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>The trial will be conducted employing a double blind study methodology; participants will be randomly assigned to each group through a drawing, neither participants nor clinicians will know to which trial group they are assigned.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Fat Percentage</measure>
    <time_frame>In order to determine change over time, body fat as a percentage of body weight will be measured before any treatment at first therapy session and measured again for comparison at the end of three weeks therapy.</time_frame>
    <description>Measured change in body fat as a percentage of total weight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Circumference Measurements</measure>
    <time_frame>In order to determine change over time, the prescribed body measurements will be summed for each participant and recorded before any treatment at first therapy session and recorded again for comparison at the end of three weeks therapy.</time_frame>
    <description>The prescribed body circumference measurements of the chest, right arm, upper-waist, mid-waist, hips, and right thigh are summed for each participant and recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Weight of Body Fat</measure>
    <time_frame>In order to determine change over time, each participants body fat weight will be calculated before any treatment at the first therapy session and calculated again to determine if there exists any change at the end of three weeks therapy.</time_frame>
    <description>The percentage of body fat for each participant was measured using Bioelectrical Impedance Analysis (BIA). That percentage is then multiplied by the total body weight of the participant in order to calculate the weight in pounds of the participants body fat.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Obesity</condition>
  <condition>Body Weight</condition>
  <condition>Fat Burn</condition>
  <condition>Cellulite</condition>
  <condition>Abdominal Fat</condition>
  <condition>Adipose Tissue Atrophy</condition>
  <arm_group>
    <arm_group_label>Care as Usual Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A randomly selected group of 20 participants who received treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol was as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Care as Usual Group</intervention_name>
    <description>Each participant randomly assigned to the &quot;Care As Usual Group&quot; will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.</description>
    <arm_group_label>Care as Usual Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Group</intervention_name>
    <description>Each participant randomly assigned to the &quot;Sham Group&quot; will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.</description>
    <arm_group_label>Sham Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Any healthy individual.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If you are pregnant, trying to get pregnant or nursing laser light therapy should be&#xD;
             received only after the end of these conditions. There is no evidence of harm to a an&#xD;
             unborn baby however there have been no safety tests either, so for medical legal&#xD;
             reasons we recommend never treating areas directly over a developing child.&#xD;
&#xD;
          -  Individuals with hypertension, light sensitive epilepsy, cancer, heart disease,&#xD;
             infectious skin disease, and severe varicose veins should not use this device.&#xD;
&#xD;
          -  People suffering from infectious and acute disease such as a fever should not use this&#xD;
             device.&#xD;
&#xD;
          -  People who have hemorrhagic disease, vascular ruptures, skin inflammation, or any&#xD;
             disease of the skin should not use this device.&#xD;
&#xD;
          -  People who have immune system dysfunction such as Leukemia, Hemophilia, etc., and&#xD;
             light sensitive persons should not use this device.&#xD;
&#xD;
          -  Individuals with a history of melanoma, raised moles, suspicious lesions, keloid scar&#xD;
             formation, or healing problems should not undergo laser light therapy.&#xD;
&#xD;
          -  Individuals with active infections, open lesions, hives, herpetic lesions, cold sores,&#xD;
             or tattoos and permanent make-up in the area of treatment should not undergo laser&#xD;
             light therapy.&#xD;
&#xD;
          -  People who have used isotretinoin (commonly known as Accutane), tetracycline, St.&#xD;
             John's Wort, or any photo sensitizing drugs in the last year should not undergo laser&#xD;
             light therapy.&#xD;
&#xD;
          -  Individuals with autoimmune diseases such as Lupus, Scleroderma, or Vitiligo should&#xD;
             not undergo laser light therapy.&#xD;
&#xD;
          -  Individuals who have pacemakers or other electro-stimulation devices surgically&#xD;
             implanted should not undergo laser light therapy.&#xD;
&#xD;
          -  Any insulin dependent individual should consult their physician before undergoing&#xD;
             laser light therapy.&#xD;
&#xD;
          -  All individuals considered &quot;vulnerable&quot; such as children, pregnant women, nursing home&#xD;
             residents or other institutionalized persons, students, employees, fetuses, prisoners,&#xD;
             and persons with decisional incapacity.&#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>Thomas A Namynanik, BS</last_name>
    <role>Study Director</role>
  </overall_official>
  <location>
    <facility>
      <name>Cross Chiropractic Center</name>
      <address>
        <city>Hixson</city>
        <state>Tennessee</state>
        <zip>37343</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <results_first_submitted>April 2, 2019</results_first_submitted>
  <results_first_submitted_qc>May 13, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2019</results_first_posted>
  <last_update_submitted>August 30, 2022</last_update_submitted>
  <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adipose, Fat, Aesthetics, Skin, Weight Reduction,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Cellulite</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03811093/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03811093/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The Trial recruitment period had a start date of January 14th and ended on January 19th 2019. (A total of 6 days) All participant recruitment and interviews were conducted at the Cross Chiropractic Center in Hixson, TN.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Care as Usual Group</title>
          <description>A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular Low-level Laser Therapy (LLLT) protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Care as Usual Group: Each participant randomly assigned to the &quot;Care As Usual Group&quot; will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.</description>
        </group>
        <group group_id="P2">
          <title>Sham Group</title>
          <description>A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no Low-level Laser Light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Sham Group: Each participant randomly assigned to the &quot;Sham Group&quot; will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy, Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to measure body fat percentage</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Care as Usual Group</title>
          <description>A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Care as Usual Group: Each participant randomly assigned to the &quot;Care As Usual Group&quot; will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.</description>
        </group>
        <group group_id="B2">
          <title>Sham Group</title>
          <description>A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Sham Group: Each participant randomly assigned to the &quot;Sham Group&quot; will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.6" spread="9.22"/>
                    <measurement group_id="B2" value="50.6" spread="13.30"/>
                    <measurement group_id="B3" value="49.46" spread="11.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percentage Body Fat</title>
          <description>Body fat percentage measured using Bioelectrical Impedance Analysis (BIA) device, measurement protocol maintained strict adherence to the manufacturers directions for use.</description>
          <population>Number of &quot;Care as Usual Group&quot; participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.&#xD;
Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.</population>
          <units>Percent Body Fat</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.38" spread="6.25"/>
                    <measurement group_id="B2" value="39.63" spread="6.90"/>
                    <measurement group_id="B3" value="40.04" spread="6.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Circumference Measurements</title>
          <description>Prior to the initial therapy session body measurements are made of each participants' chest, right arm, upper-waist, mid-waist, hips, and right thigh, they are then summed and the total recorded.</description>
          <population>Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.</population>
          <units>Inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="225.19" spread="30.64"/>
                    <measurement group_id="B2" value="222.58" spread="24.83"/>
                    <measurement group_id="B3" value="224.07" spread="27.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight of Body Fat</title>
          <description>In order to measure each participants body fat in pounds, the percentage of body fat for each participant was measured prior to the start of any therapy using Bioelectrical Impedance Analysis (BIA). The percentage is then multiplied by the total body weight of the participant in order to compute the weight in pounds of the participants body fat.</description>
          <population>Number of &quot;Care as Usual Group&quot; participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.&#xD;
Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.</population>
          <units>Pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.80" spread="28.12"/>
                    <measurement group_id="B2" value="85.81" spread="26.06"/>
                    <measurement group_id="B3" value="84.17" spread="26.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Body Fat Percentage</title>
        <description>Measured change in body fat as a percentage of total weight.</description>
        <time_frame>In order to determine change over time, body fat as a percentage of body weight will be measured before any treatment at first therapy session and measured again for comparison at the end of three weeks therapy.</time_frame>
        <population>Number of &quot;Care as Usual Group&quot; participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.&#xD;
Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Care as Usual Group</title>
            <description>A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Care as Usual Group: Each participant randomly assigned to the &quot;Care As Usual Group&quot; will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.</description>
          </group>
          <group group_id="O2">
            <title>Sham Group</title>
            <description>A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Sham Group: Each participant randomly assigned to the &quot;Sham Group&quot; will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Fat Percentage</title>
          <description>Measured change in body fat as a percentage of total weight.</description>
          <population>Number of &quot;Care as Usual Group&quot; participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.&#xD;
Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.</population>
          <units>Percentage of Body Fat</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7556" lower_limit="-2.4273" upper_limit="-1.0838"/>
                    <measurement group_id="O2" value="0.280" lower_limit="-.1194" upper_limit="0.6794"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. Change in Body Fat Percentage.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>p-value is calculated using SPSS.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>2.036</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.243</ci_lower_limit>
            <ci_upper_limit>2.828</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.&#xD;
The null hypothesis is that the distribution of Percent of Body Fat Lost or Gained is normal with mean -.83 and standard deviation 1.50218.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.20</p_value>
            <p_value_desc>The significance value has been Lilliefors corrected and represents the lower bound of the true significance.</p_value_desc>
            <method>Kolmogorov-Smirnov Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.075</p_value>
            <method>Levene's Test for Equality of Variance</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Body Circumference Measurements</title>
        <description>The prescribed body circumference measurements of the chest, right arm, upper-waist, mid-waist, hips, and right thigh are summed for each participant and recorded.</description>
        <time_frame>In order to determine change over time, the prescribed body measurements will be summed for each participant and recorded before any treatment at first therapy session and recorded again for comparison at the end of three weeks therapy.</time_frame>
        <population>Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Care as Usual Group</title>
            <description>A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Care as Usual Group: Each participant randomly assigned to the &quot;Care As Usual Group&quot; will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.</description>
          </group>
          <group group_id="O2">
            <title>Sham Group</title>
            <description>A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Sham Group: Each participant randomly assigned to the &quot;Sham Group&quot; will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Circumference Measurements</title>
          <description>The prescribed body circumference measurements of the chest, right arm, upper-waist, mid-waist, hips, and right thigh are summed for each participant and recorded.</description>
          <population>Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.</population>
          <units>Inches</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.162500" lower_limit="-12.1930" upper_limit="-8.1319"/>
                    <measurement group_id="O2" value="-3.100000" lower_limit="-5.8958" upper_limit="-.304128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change over time in measured body circumference. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. measured body circumference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>p-value is calculated using SPSS.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>7.063</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.829</ci_lower_limit>
            <ci_upper_limit>10.296</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.&#xD;
The null hypothesis is that the distribution of Total Inches Lost or Gained is normal with mean -7.136 and standard deviation 5.796.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.20</p_value>
            <p_value_desc>The significance value has been Lilliefors corrected and represents the lower bound of the true significance.</p_value_desc>
            <method>Kolmogorov-Smirnov Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.44</p_value>
            <method>Levene's Test for Equality of Variance</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Weight of Body Fat</title>
        <description>The percentage of body fat for each participant was measured using Bioelectrical Impedance Analysis (BIA). That percentage is then multiplied by the total body weight of the participant in order to calculate the weight in pounds of the participants body fat.</description>
        <time_frame>In order to determine change over time, each participants body fat weight will be calculated before any treatment at the first therapy session and calculated again to determine if there exists any change at the end of three weeks therapy.</time_frame>
        <population>Number of &quot;Care as Usual Group&quot; participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.&#xD;
Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Care as Usual Group</title>
            <description>A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular Low-level Laser Therapy (LLLT) protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Care as Usual Group: Each participant randomly assigned to the &quot;Care As Usual Group&quot; will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.</description>
          </group>
          <group group_id="O2">
            <title>Sham Group</title>
            <description>A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no Low-level Laser Light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Sham Group: Each participant randomly assigned to the &quot;Sham Group&quot; will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Weight of Body Fat</title>
          <description>The percentage of body fat for each participant was measured using Bioelectrical Impedance Analysis (BIA). That percentage is then multiplied by the total body weight of the participant in order to calculate the weight in pounds of the participants body fat.</description>
          <population>Number of &quot;Care as Usual Group&quot; participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.&#xD;
Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.</population>
          <units>Pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5183" spread="3.42558"/>
                    <measurement group_id="O2" value="-.0480" spread="2.35970"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change in body fat, measured in pounds. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. change in pounds of body fat.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>p-value is computed using SPSS.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>4.4703</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.3372</ci_lower_limit>
            <ci_upper_limit>6.6034</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.&#xD;
The null hypothesis is that the distribution of the Weight of Body Fat Lost or Gained is normal with mean -2.49 and standard deviation 3.71209.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.200</p_value>
            <p_value_desc>The significance value has been Lilliefors corrected and represents the lower bound of the true significance.</p_value_desc>
            <method>Kolmogorov-Smirnov Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.438</p_value>
            <method>Levene's Test for Equality of Variance</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Three weeks concurrent with clinical trial.</time_frame>
      <desc>Participants were instructed to immediately notify the attending clinician during each therapy session if they experienced any discomfort. Clinicians were trained to recognize any adverse effects such as extreme skin redness or blistering and instructed to report any such occurrence.</desc>
      <group_list>
        <group group_id="E1">
          <title>Care as Usual Group</title>
          <description>A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Care as Usual Group: Each participant randomly assigned to the &quot;Care As Usual Group&quot; will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.</description>
        </group>
        <group group_id="E2">
          <title>Sham Group</title>
          <description>A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.&#xD;
Sham Group: Each participant randomly assigned to the &quot;Sham Group&quot; will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Thomas A. Namynanik - Consultant to invisa-RED Technologies</name_or_title>
      <organization>Vidantis Technologies, Inc</organization>
      <phone>404 915-5938</phone>
      <email>andyn997@vidantis.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03811093
org study id: invisa-RED_Trial
nct id: NCT03811093
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The trial was designed to provide empirical evidence with which to compare the efficacy and
      safety of the invisa-RED Technology Elite Low-level Laser Therapy (LLLT) device with a sham
      device as a placebo, when both are used in the treatment of individuals to reduce body fat
      and improve body aesthetics. At the conclusion of the trial; the change in body fat
      percentage, the change in total body fat in pounds, and total inches lost of the two groups
      were statistically analyzed to determine the efficacy of the invisa-RED Technology Elite when
      used for body fat (adipose tissue) loss and/or aesthetics therapy.
The trial was designed to prove the efficacy and safety of the invisa-RED Technology Elite
      Low-level Laser Therapy (LLLT) device. The trial compared results between two groups; the
      first group was treated using a fully functional invisa-RED Technology Elite device; this
      group was designated the Usual Care Group.

      The second, a control group, was treated utilizing a nonfunctional invisa-RED Technology
      Elite device; this group is referred to as the Sham Group.The sham device consisted of an
      invisa-RED Technology Elite device that will appear to operate as the Usual Care Group device
      to the operator and participants, but the laser diodes will be disabled and will receive no
      power providing a placebo effect. If staff or a participant questions the efficacy of the
      sham device, an assertion may be made that only a near infrared, non-visible frequency of
      light, is being employed.

      The trial was conducted employing a double blind study methodology; participants were
      randomly assigned to each group through a drawing, neither participants nor clinicians knew
      to which trial group they were assigned. To ensure the double blind; treatment for the two
      groups occurred separately using clinicians exclusive to each group.

      A simplified weight loss protocol was employed based on the "Consultation Protocol" from the
      invisa-Red Training Manual. All study participants received nine (9) therapy sessions of 20
      minutes each; power settings were based on the participants Fitzpatrick Scale skin type. For
      skin types i and ii a power setting of 7 was used, for skin types iii and iv a power setting
      of 6, for skin types v and vi a power setting of 4 was employed. At the conclusion of the
      nine (9) therapy sessions; the change in weight of body fat, body fat as a percentage of
      total body weight, and inches lost of the two groups were statistically analyzed to determine
      the efficacy of the invisa-RED Technology Elite as a therapy to reduce adipose tissue. The
      occurrence of any medical errors were documented and included in the statistical analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The trial compared results between two groups of participants; the first group was treated using a fully functional device. The second, a control group, was treated utilizing a nonfunctional device. At the conclusion of nine (9) therapy sessions; the change in body fat percentage, the change in body fat in pounds, and inches lost of the two groups will be statistically analyzed to determine the efficacy of the invisa-RED Technology Elite as a weight loss therapy. Any medical errors will be included in the statistical analysis.
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: The trial will be conducted employing a double blind study methodology; participants will be randomly assigned to each group through a drawing, neither participants nor clinicians will know to which trial group they are assigned.
measure: Change in Body Fat Percentage
time frame: In order to determine change over time, body fat as a percentage of body weight will be measured before any treatment at first therapy session and measured again for comparison at the end of three weeks therapy.
description: Measured change in body fat as a percentage of total weight.
measure: Change in Body Circumference Measurements
time frame: In order to determine change over time, the prescribed body measurements will be summed for each participant and recorded before any treatment at first therapy session and recorded again for comparison at the end of three weeks therapy.
description: The prescribed body circumference measurements of the chest, right arm, upper-waist, mid-waist, hips, and right thigh are summed for each participant and recorded.
measure: Change in Weight of Body Fat
time frame: In order to determine change over time, each participants body fat weight will be calculated before any treatment at the first therapy session and calculated again to determine if there exists any change at the end of three weeks therapy.
description: The percentage of body fat for each participant was measured using Bioelectrical Impedance Analysis (BIA). That percentage is then multiplied by the total body weight of the participant in order to calculate the weight in pounds of the participants body fat.
arm group label: Care as Usual Group
arm group type: Experimental
description: A randomly selected group of 20 participants who received treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol was as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
arm group label: Sham Group
arm group type: Placebo Comparator
description: A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
intervention type: Device
intervention name: Care as Usual Group
description: Each participant randomly assigned to the "Care As Usual Group" will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.
arm group label: Care as Usual Group
intervention type: Device
intervention name: Sham Group
description: Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.
arm group label: Sham Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas A Namynanik, BS
role: Study Director
facility: 
country: United States
responsible party type: Sponsor
mesh term: Body Weight
mesh term: Cellulite
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 