xml: <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/NCT05968495</url>
    </required_header>
    <id_info>
      <org_study_id>APX-23-02</org_study_id>
      <nct_id>NCT05968495</nct_id>
    </id_info>
    <brief_title>Measuring Renuvion Soft Tissue Contraction Using Ultrasound</brief_title>
    <official_title>Measuring Renuvion Soft Tissue Contraction Using Ultrasound</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Apyx Medical</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Apyx Medical</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, single-center, non-randomized study of up to 5 subjects who are&#xD;
        receiving treatment with the Renuvion APR system following power-assisted liposuction in the&#xD;
        abdomen per investigator standard of care. Ultrasound images of soft tissue contraction will&#xD;
        be taken on abdomen prior to and during the procedure. Measurements of contraction will be&#xD;
        calculated from the ultrasound images by an ultrasonographer. All adverse events and expected&#xD;
        treatment effects will be documented.&#xD;
  &#xD;
        Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180,&#xD;
        D270, &amp; D365.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, single-center, non-randomized study of up to 5 subjects who are&#xD;
        receiving treatment with the Renuvion APR system following power-assisted liposuction in the&#xD;
        abdomen per investigator standard of care. Subjects may also have other body areas treated at&#xD;
        the same time. Demographic information, medical history, and procedure details will be&#xD;
        documented. Pre- and post-procedure care are per investigator standard of care and&#xD;
        documented. Video may be taken during the procedure.&#xD;
  &#xD;
        Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the&#xD;
        procedure. Measurements of contraction will be calculated from the ultrasound images by an&#xD;
        ultrasonographer. At baseline, photographs will be taken of the treatment areas. Surface area&#xD;
        measurements will be taken of each treatment area prior to study treatment.&#xD;
  &#xD;
        Post-procedure care will be as per investigator standard of care and documented. All adverse&#xD;
        events and expected treatment effects will be documented.&#xD;
  &#xD;
        Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180,&#xD;
        D270, &amp; D365.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Analysis of contraction</measure>
      <time_frame>Day 365</time_frame>
      <description>Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>IPR Review</measure>
      <time_frame>Day 365</time_frame>
      <description>Improvement in appearance of skin laxity in the treatment area assessed by selection of the correct post-treatment image as determined by a masked, qualitative assessment of photographs by blinded independent reviewers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physician Global Aesthetic Improvement</measure>
      <time_frame>Day 365</time_frame>
      <description>The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a PGAIS assessing overall aesthetic improvement in the treatment area</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subject Global Aesthetic Improvement</measure>
      <time_frame>Day 365</time_frame>
      <description>The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction</measure>
      <time_frame>Day 365</time_frame>
      <description>The subject will complete a Patient Satisfaction Questionnaire (PSQ)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Energy Delivered</measure>
      <time_frame>Day 0</time_frame>
      <description>Analysis of energy delivered (J/cm2)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adverse Events</measure>
      <time_frame>Day 365</time_frame>
      <description>Analysis of adverse events</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">5</enrollment>
    <condition>Skin Laxity</condition>
    <arm_group>
      <arm_group_label>Renuvion APR System Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Renuvion APR Handpiece</intervention_name>
      <description>The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.</description>
      <arm_group_label>Renuvion APR System Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who are scheduled for a procedure involving the use of Renuvion for the&#xD;
               contraction of subcutaneous soft tissue. Patients undergoing procedures involving&#xD;
               Renuvion alone and/or Renuvion following liposuction will be included.&#xD;
  &#xD;
            -  Patients who have acceptable cardiopulmonary health for outpatient surgery.&#xD;
  &#xD;
            -  Willing and able to comply with protocol requirements, including obtaining&#xD;
               study-required images/photos and assessments, and returning for follow-up visits.&#xD;
  &#xD;
            -  Willing to release rights for the use of study photos, including in potential&#xD;
               publication.&#xD;
  &#xD;
            -  Able to communicate with the site via video and/or photographs, in the event of a&#xD;
               virtual follow-up visit.&#xD;
  &#xD;
            -  Able to read, understand, sign and date the informed consent document (English only).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  BMI of greater than 35.&#xD;
  &#xD;
            -  Diabetes mellitus with A1C score &gt;7.&#xD;
  &#xD;
            -  Active cigarette smokers or nicotine vape users.&#xD;
  &#xD;
            -  History of connective tissue disease (Ehlers Danlos, Cutis Laxa, Pseudoxanthoma&#xD;
               Elasticum, Marfan's, etc.)&#xD;
  &#xD;
            -  Patients who, in the opinion of the investigator, is not an appropriate candidate for&#xD;
               the study.&#xD;
  &#xD;
            -  Patients requiring a concomitant procedure in the Renuvion treatment area that could&#xD;
               impact the ultrasound measurements or the effectiveness results.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chris Nichols</last_name>
      <role>Principal Investigator</role>
      <affiliation>Investigator</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dan Albershardt</last_name>
      <role>Principal Investigator</role>
      <affiliation>Investigator</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Pearl Plastic Surgery</name>
        <address>
          <city>Olympia</city>
          <state>Washington</state>
          <zip>98501</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Renuvion</keyword>
    <keyword>Helium Plasma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cutis Laxa</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968495
  org study id: APX-23-02
  nct id: NCT05968495
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This is a prospective, single-center, non-randomized study of up to 5 subjects who are
        receiving treatment with the Renuvion APR system following power-assisted liposuction in the
        abdomen per investigator standard of care. Ultrasound images of soft tissue contraction will
        be taken on abdomen prior to and during the procedure. Measurements of contraction will be
        calculated from the ultrasound images by an ultrasonographer. All adverse events and expected
        treatment effects will be documented.
  
        Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180,
        D270, & D365.
  This is a prospective, single-center, non-randomized study of up to 5 subjects who are
        receiving treatment with the Renuvion APR system following power-assisted liposuction in the
        abdomen per investigator standard of care. Subjects may also have other body areas treated at
        the same time. Demographic information, medical history, and procedure details will be
        documented. Pre- and post-procedure care are per investigator standard of care and
        documented. Video may be taken during the procedure.
  
        Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the
        procedure. Measurements of contraction will be calculated from the ultrasound images by an
        ultrasonographer. At baseline, photographs will be taken of the treatment areas. Surface area
        measurements will be taken of each treatment area prior to study treatment.
  
        Post-procedure care will be as per investigator standard of care and documented. All adverse
        events and expected treatment effects will be documented.
  
        Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180,
        D270, & D365.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Analysis of contraction
  time frame: Day 365
  description: Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images.
  measure: IPR Review
  time frame: Day 365
  description: Improvement in appearance of skin laxity in the treatment area assessed by selection of the correct post-treatment image as determined by a masked, qualitative assessment of photographs by blinded independent reviewers
  measure: Physician Global Aesthetic Improvement
  time frame: Day 365
  description: The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a PGAIS assessing overall aesthetic improvement in the treatment area
  measure: Subject Global Aesthetic Improvement
  time frame: Day 365
  description: The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area
  measure: Patient Satisfaction
  time frame: Day 365
  description: The subject will complete a Patient Satisfaction Questionnaire (PSQ)
  measure: Energy Delivered
  time frame: Day 0
  description: Analysis of energy delivered (J/cm2)
  measure: Adverse Events
  time frame: Day 365
  description: Analysis of adverse events
  arm group label: Renuvion APR System Treatment
  arm group type: Experimental
  description: Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time.
  intervention type: Device
  intervention name: Renuvion APR Handpiece
  description: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
  arm group label: Renuvion APR System Treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chris Nichols
  role: Principal Investigator
  affiliation: Investigator
  last name: Dan Albershardt
  role: Principal Investigator
  affiliation: Investigator
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cutis Laxa
  sharing ipd: No