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/NCT05966974</url>
    </required_header>
    <id_info>
      <org_study_id>AGN-CIP-302</org_study_id>
      <nct_id>NCT05966974</nct_id>
    </id_info>
    <brief_title>GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients</brief_title>
    <official_title>Study of Elective AGN1 LOEP in Osteopenic and Osteoporotic Subjects - a Retrospective Analysis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AgNovos Healthcare, LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AgNovos Healthcare, LLC</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>
        The study is designed as a retrospective, single-center study for subjects previously treated&#xD;
        with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will&#xD;
        collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated&#xD;
        outside of any other clinical study protocols between September 2019 and November 2022. A&#xD;
        prospective questionnaire will be included to evaluate self-reported subject experiences.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 15, 2022</start_date>
    <completion_date type="Actual">April 3, 2023</completion_date>
    <primary_completion_date type="Actual">April 3, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Subject satisfaction</measure>
      <time_frame>Through study completion, an average of 1.1 years</time_frame>
      <description>Satisfaction level of subjects as measured by a Visual Analog Scale. The scale ranges from the lowest possible satisfaction to the highest possible satisfaction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Subject Safety</measure>
      <time_frame>During the procedure</time_frame>
      <description>Incidence of all adverse events and serious adverse events occurring intraoperative determined to be at least possibly related to the procedure and/or device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Subject Safety</measure>
      <time_frame>Through study completion, an average of 1.1 years</time_frame>
      <description>Incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">44</enrollment>
    <condition>Osteoporosis</condition>
    <arm_group>
      <arm_group_label>Patients treated with AGN1 LOEP</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Osteopenic and osteoporotic subjects receiving AGN1 LOEP treatment of the proximal femur.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject has previously received AGN1 LOEP treatment between September 2019 and&#xD;
               November 2022.&#xD;
  &#xD;
            -  Subject has willingness to participate in the study.&#xD;
  &#xD;
            -  Subject can give written informed consent to allow for data collection.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The subject's AGN1 LOEP treatment was previously performed as part of a prior&#xD;
               protocoled clinical study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Vitaz</name>
        <address>
          <city>Sint-Niklaas</city>
          <zip>9100</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>December 16, 2022</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bone mineral density</keyword>
    <keyword>Femoral strength</keyword>
    <keyword>Hip fracture</keyword>
    <keyword>Local osteo-enhancement procedure</keyword>
    <keyword>LOEP</keyword>
    <keyword>Proximal femur</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoporosis</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/NCT05966974
  org study id: AGN-CIP-302
  nct id: NCT05966974
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is designed as a retrospective, single-center study for subjects previously treated
        with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will
        collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated
        outside of any other clinical study protocols between September 2019 and November 2022. A
        prospective questionnaire will be included to evaluate self-reported subject experiences.
  observational model: Cohort
  time perspective: Retrospective
  measure: Subject satisfaction
  time frame: Through study completion, an average of 1.1 years
  description: Satisfaction level of subjects as measured by a Visual Analog Scale. The scale ranges from the lowest possible satisfaction to the highest possible satisfaction.
  measure: Subject Safety
  time frame: During the procedure
  description: Incidence of all adverse events and serious adverse events occurring intraoperative determined to be at least possibly related to the procedure and/or device.
  measure: Subject Safety
  time frame: Through study completion, an average of 1.1 years
  description: Incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device.
  arm group label: Patients treated with AGN1 LOEP
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Osteoporosis
  sharing ipd: No