<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/NCT01681745</url>
  </required_header>
  <id_info>
    <org_study_id>MYO-0535</org_study_id>
    <nct_id>NCT01681745</nct_id>
  </id_info>
  <brief_title>Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects</brief_title>
  <official_title>Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to characterize the biological response of the epidermis, dermis and&#xD;
      subcutaneous tissue to treatment with the Myoscience Cryo-Touch III system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2012</start_date>
  <completion_date type="Actual">April 1, 2015</completion_date>
  <primary_completion_date type="Actual">April 1, 2015</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>
    <intervention_model_description>Subjects' abdomens treated with Myoscience device (cryoneurolysis) at various timepoints prior to an abdominoplasty. Skin examined visually and resected for histological examination.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biological Tissue Response</measure>
    <time_frame>7 days</time_frame>
    <description>The biological response of the treated tissue by the Cryo-Touch III or Cryo-Touch IV device was determined through gross pathology and histological assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs)</measure>
    <time_frame>7 days</time_frame>
    <description>All anticipated observations, adverse events and SAEs/UADEs were assessed. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) were recorded.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Histological Response of Tissue to Cold</condition>
  <arm_group>
    <arm_group_label>Cryo-Touch Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cryo-Touch III</intervention_name>
    <arm_group_label>Cryo-Touch Treatment</arm_group_label>
    <other_name>PCP 1.0</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, 18 to 70 years old&#xD;
&#xD;
          -  Subject is willing and able to give written informed consent.&#xD;
&#xD;
          -  Subject is committed to undergo an abdominoplasty procedure independent of this study.&#xD;
&#xD;
          -  Subject is willing and able to comply with study instructions and commit to all visits&#xD;
             for the duration of the study.&#xD;
&#xD;
          -  Subject is in good general health and free of any disease state or physical condition&#xD;
             that might impair evaluation or which in the investigator's opinion, expose the&#xD;
             subject to an unacceptable risk by study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is currently enrolled in an investigational drug or a device study that&#xD;
             specifically targets the abdominal area.&#xD;
&#xD;
          -  Subject currently smokes.&#xD;
&#xD;
          -  Subject has a clotting disorder and/or has used an anticoagulant (e.g., warfarin,&#xD;
             clopidogrel, etc.) within seven (7) days prior to administration of the device.&#xD;
&#xD;
          -  Subject has used oral or inhaled steroids in the last 14 days and/or has been a&#xD;
             chronic user of inhaled or oral steroids in the past such that the investigator feels&#xD;
             subject may have compromised wound healing.&#xD;
&#xD;
          -  Subject has used topical steroids in the abdominal area within the last 30 days.&#xD;
&#xD;
          -  Subject is on any systemic immunosuppressive therapy.&#xD;
&#xD;
          -  Subject has had prior surgery and/or treatment that alters the subcutaneous anatomy of&#xD;
             the target treatment sites: liposuction, cryolipolysis, or high-intensity focused&#xD;
             ultrasound.&#xD;
&#xD;
          -  History of abdominal hernia.&#xD;
&#xD;
          -  Subject has any of the following conditions:&#xD;
&#xD;
          -  Allergy or intolerance to lidocaine,&#xD;
&#xD;
          -  Other local skin condition (e.g., skin infection) at target treatment site,&#xD;
&#xD;
          -  Any physical or psychiatric condition that in the investigator's opinion would prevent&#xD;
             adequate study participation.&#xD;
&#xD;
          -  Chronic medical condition or use of medication that in the investigator's opinion&#xD;
             would affect study participation or wound healing (such as diabetes, hepatitis, HIV,&#xD;
             etc.).&#xD;
&#xD;
          -  Subject is known to be noncompliant or is unlikely to comply with the requirements of&#xD;
             the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in&#xD;
             the opinion of the investigator.&#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>
  <location>
    <facility>
      <name>77 Plastic Surgery</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <results_first_submitted>February 17, 2021</results_first_submitted>
  <results_first_submitted_qc>February 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 11, 2021</results_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cryo-Touch Treatment</title>
          <description>Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </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>
      <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
      <group_list>
        <group group_id="B1">
          <title>Cryo-Touch Treatment</title>
          <description>Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Biological Tissue Response</title>
        <description>The biological response of the treated tissue by the Cryo-Touch III or Cryo-Touch IV device was determined through gross pathology and histological assessment.</description>
        <time_frame>7 days</time_frame>
        <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Cryo-Touch Treatment</title>
            <description>Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Biological Tissue Response</title>
          <description>The biological response of the treated tissue by the Cryo-Touch III or Cryo-Touch IV device was determined through gross pathology and histological assessment.</description>
          <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs)</title>
        <description>All anticipated observations, adverse events and SAEs/UADEs were assessed. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) were recorded.</description>
        <time_frame>7 days</time_frame>
        <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Cryo-Touch Treatment</title>
            <description>Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs)</title>
          <description>All anticipated observations, adverse events and SAEs/UADEs were assessed. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) were recorded.</description>
          <population>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cryo-Touch Treatment</title>
          <description>Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="0"/>
              </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>
    <limitations_and_caveats>During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kent Jones/ Sr. Director Quality and Medical Affairs</name_or_title>
      <organization>Pacira Cryotech, Inc.</organization>
      <phone>(510)933-1513</phone>
      <email>kent.jones@pacira.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/NCT01681745
org study id: MYO-0535
nct id: NCT01681745
lead sponsor: 
has dmc: No
This study is designed to characterize the biological response of the epidermis, dermis and
      subcutaneous tissue to treatment with the Myoscience Cryo-Touch III system.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects' abdomens treated with Myoscience device (cryoneurolysis) at various timepoints prior to an abdominoplasty. Skin examined visually and resected for histological examination.
primary purpose: Treatment
masking: None (Open Label)
measure: Biological Tissue Response
time frame: 7 days
description: The biological response of the treated tissue by the Cryo-Touch III or Cryo-Touch IV device was determined through gross pathology and histological assessment.
measure: Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs)
time frame: 7 days
description: All anticipated observations, adverse events and SAEs/UADEs were assessed. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) were recorded.
arm group label: Cryo-Touch Treatment
arm group type: Experimental
description: Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
intervention type: Device
intervention name: Cryo-Touch III
arm group label: Cryo-Touch Treatment
other name: PCP 1.0
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
point of contact: 