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/NCT06034522</url>
    </required_header>
    <id_info>
      <org_study_id>DOC0478</org_study_id>
      <nct_id>NCT06034522</nct_id>
    </id_info>
    <brief_title>Clinical Investigation Evaluating the Safety and Feasibility of Adipearl</brief_title>
    <official_title>A Single-Arm, Prospective, Clinical Investigation Evaluating the Safety and Feasibility of Adipearl Implantation in the Face of Adult Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Volumina Medical S.A.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Volumina Medical S.A.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Adipearl is an injectable filler intended to be injected subcutaneously in the face.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">February 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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety of Investigational Medical Device</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Collection of Injection Site Reactions and Adverse Events during the study.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Mid-face Volume Deficiency</condition>
    <arm_group>
      <arm_group_label>Face correction with Investigational device</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will be injected with the investigational device in the face.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Adipearl</intervention_name>
      <description>Injection of the investigational device in the face.</description>
      <arm_group_label>Face correction with Investigational device</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject having given freely and expressly informed consent;&#xD;
  &#xD;
            -  Subject deemed by the Investigator to be medically fit for injection of the product;&#xD;
  &#xD;
            -  Female or male subjects aged 22 to 65 years (inclusive);&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or nursing woman or planning a pregnancy during the study.&#xD;
  &#xD;
            -  Subject who had been deprived of their freedom by administrative or legal decision or&#xD;
               who is under guardianship.&#xD;
  &#xD;
            -  Subject participating to another research study.&#xD;
  &#xD;
            -  Subject with the presence of any condition, which in the opinion of the Principal&#xD;
               Investigator, that makes her/him unable to complete the study per protocol.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Art Clinic</name>
        <address>
          <city>Stockholm</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Per Heden</last_name>
        <phone>0046 70-858 42 55</phone>
        <email>per@drheden.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06034522
  org study id: DOC0478
  nct id: NCT06034522
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Adipearl is an injectable filler intended to be injected subcutaneously in the face.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Safety of Investigational Medical Device
  time frame: Up to 6 months
  description: Collection of Injection Site Reactions and Adverse Events during the study.
  arm group label: Face correction with Investigational device
  arm group type: Experimental
  description: Subjects will be injected with the investigational device in the face.
  intervention type: Device
  intervention name: Adipearl
  description: Injection of the investigational device in the face.
  arm group label: Face correction with Investigational device
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Sweden
  responsible party type: Sponsor