<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/NCT03800563</url>
  </required_header>
  <id_info>
    <org_study_id>ALM-Lipo-002</org_study_id>
    <nct_id>NCT03800563</nct_id>
  </id_info>
  <brief_title>Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System</brief_title>
  <official_title>The Safety and Efficacy of Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alma Lasers</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alma Lasers</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multi-center, prospective, open-label, single arm study. The study aims to evaluate the&#xD;
      safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife&#xD;
      system. The study will include twenty (20) eligible subjects, that are willing to undergo&#xD;
      abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of&#xD;
      this study group should also be eligible for facial fat grafting. Follow up visits to&#xD;
      evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Actual">May 20, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 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>
  </study_design_info>
  <primary_outcome>
    <measure>Correct Identification of Before and After Photographs</measure>
    <time_frame>3 months</time_frame>
    <description>Over 90% success in correct identification of before and after body contouring photos by blinded evaluators.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Laser Assisted Liposuction</condition>
  <arm_group>
    <arm_group_label>Laser assisted liposuction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser Assisted Liposuction with the LipoLife system. Each subject underwent laser assisted liposuction surgery w/wo facial fat grafting , using the LipoLifeTM system. Pre-surgery evaluation visit was carried out 1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take place at 1, 3 and 6 months after the surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LipoLife system</intervention_name>
    <description>Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.</description>
    <arm_group_label>Laser assisted liposuction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with excessive fat in the lower abdomen or subjects with excessive fat in the&#xD;
             outer thighs that are willing to undergo laser-assisted liposuction&#xD;
&#xD;
          -  Estimated fat harvesting of 1-3 liters&#xD;
&#xD;
          -  Subjects (5-20) eligible for facial fat grafting of at least 5 cc for each cheek&#xD;
&#xD;
          -  Between 18 and 70 years of age&#xD;
&#xD;
          -  Provided written Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;35&#xD;
&#xD;
          -  Sever skin laxity&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Presence of known malignancy&#xD;
&#xD;
          -  Active infection in the treatment area&#xD;
&#xD;
          -  History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE])&#xD;
&#xD;
          -  History of connective, metabolic or atrophic skin disease&#xD;
&#xD;
          -  History of keloid scarring&#xD;
&#xD;
          -  Chronic use (&gt;7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within&#xD;
             15 days prior to enrollment&#xD;
&#xD;
          -  Subjects with immune system diseases&#xD;
&#xD;
          -  Subject unable to follow post-treatment instructions&#xD;
&#xD;
          -  Any other reason that in the opinion of the investigator, prevents the subject from&#xD;
             participating in the study or compromise the subject safety.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason N. Pozner, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sanctuary Plastic Surgery</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lior Heller, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yitzhak Shamir Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sanctuary Plastic Surgery</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yitzhak Shamir Medical Center</name>
      <address>
        <city>Be'er Ya'aqov</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>August 7, 2022</results_first_submitted>
  <results_first_submitted_qc>September 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 25, 2022</results_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>October 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03800563/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03800563/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Laser Assisted Liposuction of Abdominal Excessive Fat</title>
          <description>Laser Assisted Liposuction with the LipoLife system. LipoLife system: Abdominal/ Outer thighs Laser Assisted Liposuction. Added: &quot;Each subject underwent laser assisted liposuction surgery w/wo facial fat grafting , using the LipoLifeTM system. Pre-surgery evaluation visit was carried out 1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take place at 1, 3 and 6 months after the surgery.&quot; Seven subjects out of the study group underwent facial fat grafting.</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_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Laser Assisted Liposuction</title>
          <description>Laser Assisted Liposuction with the LipoLife system.&#xD;
LipoLife system: Abdominal/ Outer thighs Laser Assisted Liposuction. Seven subjects out of the study group underwent facial fat grafting.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.3" spread="2.3"/>
                  </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="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Correct Identification of Before and After Photographs</title>
        <description>Over 90% success in correct identification of before and after body contouring photos by blinded evaluators.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Laser Assisted Liposuction</title>
            <description>Laser Assisted Liposuction with the LipoLife system.&#xD;
LipoLife system: Abdominal/ Outer thighs Laser Assisted Liposuction. Seven subjects out of the study group underwent facial fat grafting.</description>
          </group>
        </group_list>
        <measure>
          <title>Correct Identification of Before and After Photographs</title>
          <description>Over 90% success in correct identification of before and after body contouring photos by blinded evaluators.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Duration of each subject's participation was up to 8 months from enrollment to termination. Adverse events data was to be reported at any time during or after the use of the study device.</time_frame>
      <desc>Definitions of adverse event and serious adverse event used to collect adverse event information do not differ from the clinicaltrials.gov Definitions</desc>
      <group_list>
        <group group_id="E1">
          <title>Laser Assisted Liposuction</title>
          <description>Laser Assisted Liposuction with the LipoLife system.&#xD;
LipoLife system: Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.</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"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 10.0</default_vocab>
        <default_assessment>Non-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="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>urinary track infection</sub_title>
                <description>An infection in the urinary system that begins when microorganisms cling to the opening of the urethra (the canal from the bladder) and begin to multiply.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <description>localized bleeding outside of skin blood vessels.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </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 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 Meital Grafi-Cohen</name_or_title>
      <organization>Alma Lasers</organization>
      <phone>+972-523708780</phone>
      <email>meital.grafi@almalasers.co.il</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/NCT03800563
org study id: ALM-Lipo-002
nct id: NCT03800563
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Multi-center, prospective, open-label, single arm study. The study aims to evaluate the
      safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife
      system. The study will include twenty (20) eligible subjects, that are willing to undergo
      abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of
      this study group should also be eligible for facial fat grafting. Follow up visits to
      evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Correct Identification of Before and After Photographs
time frame: 3 months
description: Over 90% success in correct identification of before and after body contouring photos by blinded evaluators.
arm group label: Laser assisted liposuction
arm group type: Experimental
description: Laser Assisted Liposuction with the LipoLife system. Each subject underwent laser assisted liposuction surgery w/wo facial fat grafting , using the LipoLifeTM system. Pre-surgery evaluation visit was carried out 1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take place at 1, 3 and 6 months after the surgery.
intervention type: Device
intervention name: LipoLife system
description: Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.
arm group label: Laser assisted liposuction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jason N. Pozner, M.D.
role: Principal Investigator
affiliation: Sanctuary Plastic Surgery
last name: Lior Heller, M.D.
role: Principal Investigator
affiliation: Yitzhak Shamir Medical Center
facility: 
facility: 
country: Israel
country: United States
responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 