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/NCT06010433</url>
    </required_header>
    <id_info>
      <org_study_id>S050/2018</org_study_id>
      <nct_id>NCT06010433</nct_id>
    </id_info>
    <brief_title>CERAMENT G Device Registry</brief_title>
    <official_title>CERAMENT G Device Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BONESUPPORT AB</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>BONESUPPORT AB</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 an Observational Device Registry Study of CERAMENT|G in normal use in accordance with&#xD;
        the IFU. It will run for a period of three years from enrolment of the first patient into the&#xD;
        Study at each Site, before being subject to review. A Device Registry is a form of&#xD;
        observational study that concerns the performance of a device in normal use. It is intended&#xD;
        to collect data that is reflective of 'real world' device performance.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 22, 2023</start_date>
    <completion_date type="Anticipated">September 22, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 22, 2028</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>12 Months</target_duration>
    <primary_outcome>
      <measure>Primary Outcomes</measure>
      <time_frame>12 months</time_frame>
      <description>• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary Outcome</measure>
      <time_frame>12 months</time_frame>
      <description>Bone healing at final follow-up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary Outcome</measure>
      <time_frame>6 and 12 months</time_frame>
      <description>Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 &amp; 12 months, if normally conducted</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary Outcome</measure>
      <time_frame>12 months</time_frame>
      <description>(Recurrence of) infection/revision surgery</description>
    </secondary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Chronic Osteomyelitis</condition>
    <condition>Fracture Related Infection</condition>
    <condition>Diabetic Foot Osteomyelitis</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CERAMENT G</intervention_name>
      <description>Primary mode of action is to be a resorbable ceramic bone graft substitute intended to fill gaps and voids in the skeleton system to promote bone healing. CERAMENT ™|G provides a void/gap filler that during the surgical procedure can augment hardware and bone alignments.&#xD;
  Secondary mode of action is to prevent colonization of Gentamicin sensitive microorganisms in order to protect bone healing.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The racial, gender and ethnic characteristics of the individuals approached for&#xD;
          participation in this Observational Registry Study shall reflect the demographics of&#xD;
          patients that would ordinarily receive CERAMENT|G for the treatment of their condition at&#xD;
          the designated investigative centres. No individuals shall be excluded from participation&#xD;
          in the Observational Registry Study based on race, nationality, ethnicity, gender, or&#xD;
          sexuality&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years and over (on the day of surgery)&#xD;
  &#xD;
            -  receive CERAMENT|G as a component of their treatment at a participating, contracted&#xD;
               centre or healthcare provider, in accordance with the IFU for the implanted product&#xD;
  &#xD;
            -  In receipt of patient information leaflet and have signed appropriately designed&#xD;
               informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any exclusion criteria as per IFU for CERAMENT|G&#xD;
  &#xD;
            -  Any off-label use&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Brian M Bartholdi</last_name>
      <phone>16178923927</phone>
      <email>brian.bartholdi@bonesupport.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteomyelitis</mesh_term>
      <mesh_term>Diabetic Foot</mesh_term>
    </condition_browse>
    <!-- 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/NCT06010433
  org study id: S050/2018
  nct id: NCT06010433
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This is an Observational Device Registry Study of CERAMENT|G in normal use in accordance with
        the IFU. It will run for a period of three years from enrolment of the first patient into the
        Study at each Site, before being subject to review. A Device Registry is a form of
        observational study that concerns the performance of a device in normal use. It is intended
        to collect data that is reflective of 'real world' device performance.
  observational model: Case-Only
  time perspective: Prospective
  measure: Primary Outcomes
  time frame: 12 months
  description: • Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.
  measure: Secondary Outcome
  time frame: 12 months
  description: Bone healing at final follow-up
  measure: Secondary Outcome
  time frame: 6 and 12 months
  description: Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 & 12 months, if normally conducted
  measure: Secondary Outcome
  time frame: 12 months
  description: (Recurrence of) infection/revision surgery
  intervention type: Device
  intervention name: CERAMENT G
  description: Primary mode of action is to be a resorbable ceramic bone graft substitute intended to fill gaps and voids in the skeleton system to promote bone healing. CERAMENT ™|G provides a void/gap filler that during the surgical procedure can augment hardware and bone alignments.
  Secondary mode of action is to prevent colonization of Gentamicin sensitive microorganisms in order to protect bone healing.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brian M Bartholdi
  phone: 16178923927
  email: brian.bartholdi@bonesupport.com
  responsible party type: Sponsor
  mesh term: Osteomyelitis
  mesh term: Diabetic Foot