<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/NCT03762811</url>
  </required_header>
  <id_info>
    <org_study_id>CPR-00002</org_study_id>
    <nct_id>NCT03762811</nct_id>
  </id_info>
  <brief_title>Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix</brief_title>
  <official_title>Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NanoFUSE Biologics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NanoFUSE Biologics, LLC</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This purpose of this study is to determine fusion rates and compare clinical outcomes of the&#xD;
      NanoFUSE® Bioactive Matrix during post-market clinical use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are&#xD;
      not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and&#xD;
      pelvis). These defects may be surgically created osseous defects or osseous defects created&#xD;
      from traumatic injury to bone. NanoFUSE® must be used with autograft as a bone graft extender&#xD;
      in the posterolateral spine and pelvis. This product provides a bone graft substitute that&#xD;
      remodels into the recipient's skeletal system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</primary_completion_date>
  <phase>Phase 4</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>Radiographic Success that indicates patient achieving fused or probably fused status.</measure>
    <time_frame>12 months</time_frame>
    <description>at 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall patient success</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>Overall patient success will be based on all clinical and radiographic evaluation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Bone; Degeneration</condition>
  <arm_group>
    <arm_group_label>NanoFUSE® PMCF</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>NanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NanoFUSE® Bioactive Matrix</intervention_name>
    <description>NanoFUSE® is placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.</description>
    <arm_group_label>NanoFUSE® PMCF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Skeletally mature&#xD;
&#xD;
          -  Medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix&#xD;
             consistent with product labeling&#xD;
&#xD;
          -  Psychosocially, mentally, and physically able to fully comply with the protocol,&#xD;
             including the post-operative regimen, requires follow-up visits, filling out required&#xD;
             forms, and the ability to understand and give written informed consent&#xD;
&#xD;
          -  Retrospective data collection must be allowed by the IRB and all information&#xD;
             deidentified&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous fusion surgery of the proposed site&#xD;
&#xD;
          -  Use of chronic medications known to affect the skeleton (e.g. glucocorticoid usage &gt;&#xD;
             10mg/day)&#xD;
&#xD;
          -  Pregnant or female intending to become pregnant during this study period&#xD;
&#xD;
          -  Obesity (BMI &gt;40kg/m2)&#xD;
&#xD;
          -  Systemic infection or infection at the surgical site&#xD;
&#xD;
          -  Current or past substance abuse&#xD;
&#xD;
          -  Poor general healthy or any concurrent disease process that would place the patient in&#xD;
             excessive risk to surgery (e.g. significant circulatory or pulmonary problems, cardiac&#xD;
             disease&#xD;
&#xD;
          -  Medical condition that would interfere with post-operative assessments and care&#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>Holly Cole</last_name>
    <phone>978-358-7307</phone>
    <phone_ext>1004</phone_ext>
    <email>hollycole@rqmis.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ashley Lyons</last_name>
    <phone>978-358-7307</phone>
    <phone_ext>1005</phone_ext>
    <email>ashleylyons@rqmis.com</email>
  </overall_contact_backup>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Demineralized Bone Matrix</keyword>
  <keyword>Bone Graft</keyword>
  <keyword>Fusion</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03762811
org study id: CPR-00002
nct id: NCT03762811
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This purpose of this study is to determine fusion rates and compare clinical outcomes of the
      NanoFUSE® Bioactive Matrix during post-market clinical use.
NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are
      not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and
      pelvis). These defects may be surgically created osseous defects or osseous defects created
      from traumatic injury to bone. NanoFUSE® must be used with autograft as a bone graft extender
      in the posterolateral spine and pelvis. This product provides a bone graft substitute that
      remodels into the recipient's skeletal system.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Radiographic Success that indicates patient achieving fused or probably fused status.
time frame: 12 months
description: at 12 months
measure: Overall patient success
time frame: 12 months postoperatively
description: Overall patient success will be based on all clinical and radiographic evaluation
arm group label: NanoFUSE® PMCF
arm group type: Other
description: NanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon.
intervention type: Device
intervention name: NanoFUSE® Bioactive Matrix
description: NanoFUSE® is placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.
arm group label: NanoFUSE® PMCF
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Holly Cole
phone: 978-358-7307
phone ext: 1004
email: hollycole@rqmis.com
last name: Ashley Lyons
phone: 978-358-7307
phone ext: 1005
email: ashleylyons@rqmis.com
responsible party type: Sponsor