<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/NCT03756350</url>
  </required_header>
  <id_info>
    <org_study_id>CS1317</org_study_id>
    <nct_id>NCT03756350</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen)</brief_title>
  <official_title>Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non-invasive Fat Reduction of the Abdomen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Venus Concept</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Venus Concept</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen.&#xD;
      The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen.&#xD;
      Each subject will receive a single study treatment. Subjects will be followed at six and&#xD;
      twelve weeks post treatment. Twelve week outcomes will be compared to baseline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open-label baseline controlled evaluator-blind multi-centre study evaluating a 1060nm diode&#xD;
      laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50&#xD;
      subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single&#xD;
      study treatment which takes approximately 25 minutes. Subjects will be followed at six and&#xD;
      twelve weeks post treatment. Twelve week outcomes will be compared to baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2018</start_date>
  <completion_date type="Actual">July 2, 2019</completion_date>
  <primary_completion_date type="Actual">July 2, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Blinded reviewer will evaluate the pre and post photos</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators</measure>
    <time_frame>Week 12 vs baseline</time_frame>
    <description>Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fat Thickness</measure>
    <time_frame>week 12</time_frame>
    <description>Change in thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction</measure>
    <time_frame>Week 12</time_frame>
    <description>Subject satisfaction with treatment at 12 weeks after treatment using the 5-point Likert Subject Satisfaction Scale. A score of 4 is very satisfied and 0 is very unsatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Pain</measure>
    <time_frame>Week 1</time_frame>
    <description>Subject assessment of discomfort and pain post treatment as measured using the Wong Baker Faces Scale, which is a 10 point scale with 10 being the worst pain ever and 0 being no pain.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Fat Atrophy</condition>
  <arm_group>
    <arm_group_label>Treatment subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>1060nm diode laser</intervention_name>
    <description>Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.</description>
    <arm_group_label>Treatment subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  able to read, understand and voluntarily provide written informed consent&#xD;
&#xD;
          -  healthy male or female &gt; 18 years of age seeking treatment for unwanted fat in the&#xD;
             abdomen&#xD;
&#xD;
          -  BMI score is less then 30&#xD;
&#xD;
          -  agree to not making any major changes in their diet or lifestyle during the course of&#xD;
             the study&#xD;
&#xD;
          -  able and willing to comply with the treatment / follow up schedule and requirements&#xD;
&#xD;
          -  women of child-bearing age are required to be using a reliable method of birth control&#xD;
             at least 3 months prior to study enrolment and for the duration of the study, have a&#xD;
             negative urine pregnancy test baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant in the last 3 months intending to become pregnant, postpartum or nursing in&#xD;
             the last 6 months&#xD;
&#xD;
          -  any previous liposuction / lipo-sculpture or any type of surgical procedure in the&#xD;
             treatment area in the past 12 months&#xD;
&#xD;
          -  history of immunosuppression / immune deficiency disorders including AIDS and HIV&#xD;
             infection, or use of immunosuppressive medications, 6 month prior to and during the&#xD;
             course of the study&#xD;
&#xD;
          -  History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive&#xD;
             bleeding&#xD;
&#xD;
          -  Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted),&#xD;
             anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of&#xD;
             treatment&#xD;
&#xD;
          -  Having a history of skin cancer or any other cancer in the area to be treated,&#xD;
             including presence of malignant or pre-malignant pigmented lesions&#xD;
&#xD;
          -  Having a permanent implant in the treatment area such as a metal plate or injected&#xD;
             chemical substance such as silicone pr parenteral gold therapy (gold sodium&#xD;
             thiomalate)&#xD;
&#xD;
          -  Use of medications, herbs or food supplements and vitamins known to induce&#xD;
             photosensitivity to light exposure at the wavelength used history of photosensitivity&#xD;
             disorder&#xD;
&#xD;
          -  Suffering from significant skin conditions in the treatment area or inflammatory skin&#xD;
             conditions including but not limited to open lacerations, abrasions, herpes sores,&#xD;
             cold sores, active infections&#xD;
&#xD;
          -  Tattoos in the treatment area&#xD;
&#xD;
          -  Poor quality skin (laxity)&#xD;
&#xD;
          -  Abdominal wall, muscular abnormality or hernia on physical examination&#xD;
&#xD;
          -  Unstable weight within the last 6 months (+ or - 3% weight change in the prior six&#xD;
             months)&#xD;
&#xD;
          -  Participation in another clinical study involving the same anatomical areas within the&#xD;
             last 6 months&#xD;
&#xD;
          -  History of keloid and hypertrophic scar formation or poor wound healing in the&#xD;
             treatment area&#xD;
&#xD;
          -  As per the investigators discretion any physician or mental condition which may make&#xD;
             it unsafe for the subject to participate&#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>Suzanne Kilmer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skin and Laser Surgery Center of Northern California</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffery Kenkel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laser and Skin Surgery Center of Northern California</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwestern Medical Center Department of Plastic Surgery</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Decorato JW, Chen B, Sierra R. Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser. Lasers Surg Med. 2017 Jul;49(5):480-489. doi: 10.1002/lsm.22625. Epub 2017 Jan 19.</citation>
    <PMID>28103642</PMID>
  </results_reference>
  <results_reference>
    <citation>Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks. Dermatol Surg. 2018 Mar;44(3):388-396. doi: 10.1097/DSS.0000000000001298.</citation>
    <PMID>28902034</PMID>
  </results_reference>
  <results_reference>
    <citation>McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available.</citation>
    <PMID>21779417</PMID>
  </results_reference>
  <results_reference>
    <citation>Schilling L, Saedi N, Weiss R. 1060 nm Diode Hyperthermic Laser Lipolysis:The Latest in Non-Invasive Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52.</citation>
    <PMID>28095532</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>April 26, 2023</results_first_submitted>
  <results_first_submitted_qc>June 12, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2023</results_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>abdomen</keyword>
  <keyword>adipose</keyword>
  <keyword>fat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03756350/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Subjects</title>
          <description>Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.&#xD;
1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment Subjects</title>
          <description>Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.&#xD;
1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45" lower_limit="26" upper_limit="62"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators</title>
        <description>Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks</description>
        <time_frame>Week 12 vs baseline</time_frame>
        <population>All subjects who had baseline and Week 12 follow up photos.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Subjects</title>
            <description>Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.&#xD;
1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators</title>
          <description>Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks</description>
          <population>All subjects who had baseline and Week 12 follow up photos.</population>
          <units>Photo sets</units>
          <param>Number</param>
          <units_analyzed>Photo sets</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Photo sets</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fat Thickness</title>
        <description>Change in thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline</description>
        <time_frame>week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Subjects</title>
            <description>Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.&#xD;
1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fat Thickness</title>
          <description>Change in thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline</description>
          <units>Percent change in abdominal fat</units>
          <param>Median</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.8" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Satisfaction</title>
        <description>Subject satisfaction with treatment at 12 weeks after treatment using the 5-point Likert Subject Satisfaction Scale. A score of 4 is very satisfied and 0 is very unsatisfied.</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Subjects</title>
            <description>Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.&#xD;
1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction</title>
          <description>Subject satisfaction with treatment at 12 weeks after treatment using the 5-point Likert Subject Satisfaction Scale. A score of 4 is very satisfied and 0 is very unsatisfied.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Pain</title>
        <description>Subject assessment of discomfort and pain post treatment as measured using the Wong Baker Faces Scale, which is a 10 point scale with 10 being the worst pain ever and 0 being no pain.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Subjects</title>
            <description>Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.&#xD;
1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Pain</title>
          <description>Subject assessment of discomfort and pain post treatment as measured using the Wong Baker Faces Scale, which is a 10 point scale with 10 being the worst pain ever and 0 being no pain.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks following treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment Subjects</title>
          <description>Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.&#xD;
1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.</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="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Not visible, but palpable nodules</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </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>Dr. Matthew Gronski</name_or_title>
      <organization>Venus Concept</organization>
      <phone>(888) 907-0115</phone>
      <email>mgronski@venusconcept.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/NCT03756350
org study id: CS1317
nct id: NCT03756350
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen.
      The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen.
      Each subject will receive a single study treatment. Subjects will be followed at six and
      twelve weeks post treatment. Twelve week outcomes will be compared to baseline.
Open-label baseline controlled evaluator-blind multi-centre study evaluating a 1060nm diode
      laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50
      subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single
      study treatment which takes approximately 25 minutes. Subjects will be followed at six and
      twelve weeks post treatment. Twelve week outcomes will be compared to baseline.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Blinded reviewer will evaluate the pre and post photos
measure: Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators
time frame: Week 12 vs baseline
description: Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks
measure: Change in Fat Thickness
time frame: week 12
description: Change in thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline
measure: Subject Satisfaction
time frame: Week 12
description: Subject satisfaction with treatment at 12 weeks after treatment using the 5-point Likert Subject Satisfaction Scale. A score of 4 is very satisfied and 0 is very unsatisfied.
measure: Treatment Pain
time frame: Week 1
description: Subject assessment of discomfort and pain post treatment as measured using the Wong Baker Faces Scale, which is a 10 point scale with 10 being the worst pain ever and 0 being no pain.
arm group label: Treatment subjects
arm group type: Experimental
description: Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.
intervention type: Device
intervention name: 1060nm diode laser
description: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.
arm group label: Treatment subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Suzanne Kilmer, MD
role: Principal Investigator
affiliation: Skin and Laser Surgery Center of Northern California
last name: Jeffery Kenkel, MD
role: Principal Investigator
affiliation: UT Southwestern
facility: 
facility: 
country: United States
citation: Decorato JW, Chen B, Sierra R. Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser. Lasers Surg Med. 2017 Jul;49(5):480-489. doi: 10.1002/lsm.22625. Epub 2017 Jan 19.
PMID: 28103642
citation: Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks. Dermatol Surg. 2018 Mar;44(3):388-396. doi: 10.1097/DSS.0000000000001298.
PMID: 28902034
citation: McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available.
PMID: 21779417
citation: Schilling L, Saedi N, Weiss R. 1060 nm Diode Hyperthermic Laser Lipolysis:The Latest in Non-Invasive Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52.
PMID: 28095532
responsible party type: Sponsor
mesh term: Atrophy
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 