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/NCT05997121</url>
    </required_header>
    <id_info>
      <org_study_id>SV005</org_study_id>
      <nct_id>NCT05997121</nct_id>
    </id_info>
    <brief_title>Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease</brief_title>
    <acronym>TLIF</acronym>
    <official_title>Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>SpineVision</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>EVAMED</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>SpineVision</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>
        The goal of this observational study is to confirm the safety and efficacy of the Hexanium&#xD;
        TLIF system in the treatment of skeletally mature patients suffering from degenerative disc&#xD;
        disease (disease that occurs when the spinal disk break down).&#xD;
  &#xD;
        Part of their standard of care, participants will be questioned on their back and leg pains,&#xD;
        their disability and if they have encountered any adverse effects since the Hexanium TLIF&#xD;
        system implant surgery. Those data will be collected up to twenty four (24) months after the&#xD;
        Hexanium TLIF system implant surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical&#xD;
        follow-up study. This means that either subjects already implanted with the Hexanium TLIF&#xD;
        system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF&#xD;
        (prospective subjects) can be enrolled in the study.&#xD;
  &#xD;
        Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system&#xD;
        implant procedure will be collected; key data include back and leg Visual Analogue Score&#xD;
        (VAS), Oswestry Disability Index (ODI) score, and adverse events.&#xD;
  &#xD;
        Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 9, 2021</start_date>
    <completion_date type="Anticipated">October 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2027</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of serious adverse device and/or procedure related events</measure>
      <time_frame>Month 24</time_frame>
      <description>Rate of the serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change of the Oswestry Disability Index (ODI)</measure>
      <time_frame>Month 12</time_frame>
      <description>ODI mean score at Month 12 will be compared to the ODI mean score at baseline.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fusion success</measure>
      <time_frame>Month 2, month 6, month 12 and month 24</time_frame>
      <description>Fusion rate will be analyzed and compared to the state of the art.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of the Oswestry Disability Index (ODI)</measure>
      <time_frame>Month 2, month 6, and month 24</time_frame>
      <description>Mean ODI score evolution score will be analyzed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of the back and leg Visual Analogue Score (VAS)</measure>
      <time_frame>Month 2, month 6, month 12 and month 24</time_frame>
      <description>Back and leg VAS assessment will be analyzed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of revision surgery at implant site</measure>
      <time_frame>Month 2, month 6, month 12 and month 24</time_frame>
      <description>Rate of revision surgery at implant site will be analyzed and compared to the state of the art.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">187</enrollment>
    <condition>Intervertebral Disc Degeneration</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transforaminal lumbar interbody fusion</intervention_name>
      <description>Transforaminal Lumbar Interbody Fusion indicates a surgical approach in the lumbar spine to fuse the discal space between two vertebrae. These are joined by removing the disc and placing a cage in its place to restore the vertebral height. Screws and rods are also added to maintain the level secure while the bones fuse together.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients eligible for treatment or already treated with the Hexanium TLIF system device&#xD;
          will be offered to participate in the study; this applies to primary care clinic.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF&#xD;
               system (not prior to July 2021)&#xD;
  &#xD;
            -  Patient of 18 years old or more&#xD;
  &#xD;
            -  Patient has provided signed informed consent, or did not oppose to his/her data&#xD;
               collection, per local regulation&#xD;
  &#xD;
          Exclusion Criteria: contra-indication&#xD;
  &#xD;
            -  Infection, local to the operative site&#xD;
  &#xD;
            -  Signed of local inflammation&#xD;
  &#xD;
            -  Fever or leukocytosis&#xD;
  &#xD;
            -  Morbid obesity&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Paediatric cases, or patient still having general skeletal growth&#xD;
  &#xD;
            -  Spondylolisthesis unable to be reduced to Grade I&#xD;
  &#xD;
            -  Suspected or documented allergy or intolerance to metal&#xD;
  &#xD;
            -  Any case where the implant components selected for use would be too large or too small&#xD;
               to achieve a successful result&#xD;
  &#xD;
            -  Any patient having inadequate tissue coverage over the operative site or inadequate&#xD;
               bone stock or quality&#xD;
  &#xD;
            -  Any patient in which implant utilization would interfere with anatomical structures or&#xD;
               expected physiological performance&#xD;
  &#xD;
            -  Prior fusion at the level to be treated&#xD;
  &#xD;
            -  Any case not needing a bone graft or fusion&#xD;
  &#xD;
            -  Any abnormality present which affects the normal process of bone remodelling&#xD;
               including, but not limited to severe osteoporosis involving spine, bone absorption,&#xD;
               osteopenia, primary or metastasis tumours involving the spine, active infection at the&#xD;
               site or certain metabolic disorders affecting osteogenesis&#xD;
  &#xD;
            -  Any other condition which would preclude the potential benefit of spinal implant&#xD;
               surgery, such as the presence of tumours or congenital abnormalities, fracture local&#xD;
               to operating site, elevation of segmentation rate unexplained by other diseases,&#xD;
               elevation of white blood count (WBC), or marked left shift in the WBC differential&#xD;
               count&#xD;
  &#xD;
            -  Mental illness&#xD;
  &#xD;
            -  Any patient unwilling to cooperate with post-operative instructions&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Noel Graziani, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hopital Privé Clairval</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Renaud Duchenes</last_name>
      <phone>+33 6 86 16 61 91</phone>
      <email>r.duchenes@spinevision.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hanta Ranaivoson</last_name>
      <email>h.ranaivoson@spinevision.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Clinique du dos Terrefort</name>
        <address>
          <city>Bruges</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ibrahim Obeid, Doctor</last_name>
        <email>ibrahim.obeid@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Ibrahim Obeid, Doctor</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Louis Boissière, Doctor</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Clinique Saint Charles</name>
        <address>
          <city>Lyon</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emmanuel Favreul, Doctor</last_name>
        <email>emmanuel.favreul@wanadoo.fr</email>
      </contact>
      <investigator>
        <last_name>Emmanuel Favreul, Doctor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hopital privé Clairval</name>
        <address>
          <city>Marseille</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Noel Graziani, Professor</last_name>
        <email>graziani.noel@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Noel Graziani, Professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CHRU Nancy</name>
        <address>
          <city>Nancy</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nacer Mansouri, Doctor</last_name>
        <email>mansouri.nz@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Nacer Mansouri, Doctor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Polyclinique Majorelle</name>
        <address>
          <city>Nancy</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aurélie Toquart, Doctor</last_name>
        <email>a.toquart@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Aurélie Toquart, Doctor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Clinicque Générale Beaulieu</name>
        <address>
          <city>Geneva</city>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Frédéric Schils, Doctor</last_name>
        <email>fs@schilsneurosurgery.com</email>
      </contact>
      <investigator>
        <last_name>Frédéric Schils, Doctor</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Renato Gondar, Doctor</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lumbar</keyword>
    <keyword>Spine</keyword>
    <keyword>Arthrodesis</keyword>
    <keyword>Fusion</keyword>
    <keyword>Stabilization</keyword>
    <keyword>Oswestry disability index</keyword>
    <keyword>Visual Analogue Score</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intervertebral Disc Degeneration</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/NCT05997121
  org study id: SV005
  nct id: NCT05997121
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The goal of this observational study is to confirm the safety and efficacy of the Hexanium
        TLIF system in the treatment of skeletally mature patients suffering from degenerative disc
        disease (disease that occurs when the spinal disk break down).
  
        Part of their standard of care, participants will be questioned on their back and leg pains,
        their disability and if they have encountered any adverse effects since the Hexanium TLIF
        system implant surgery. Those data will be collected up to twenty four (24) months after the
        Hexanium TLIF system implant surgery.
  The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical
        follow-up study. This means that either subjects already implanted with the Hexanium TLIF
        system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF
        (prospective subjects) can be enrolled in the study.
  
        Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system
        implant procedure will be collected; key data include back and leg Visual Analogue Score
        (VAS), Oswestry Disability Index (ODI) score, and adverse events.
  
        Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.
  observational model: Cohort
  time perspective: Other
  measure: Incidence of serious adverse device and/or procedure related events
  time frame: Month 24
  description: Rate of the serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.
  measure: Change of the Oswestry Disability Index (ODI)
  time frame: Month 12
  description: ODI mean score at Month 12 will be compared to the ODI mean score at baseline.
  measure: Fusion success
  time frame: Month 2, month 6, month 12 and month 24
  description: Fusion rate will be analyzed and compared to the state of the art.
  measure: Change of the Oswestry Disability Index (ODI)
  time frame: Month 2, month 6, and month 24
  description: Mean ODI score evolution score will be analyzed.
  measure: Change of the back and leg Visual Analogue Score (VAS)
  time frame: Month 2, month 6, month 12 and month 24
  description: Back and leg VAS assessment will be analyzed.
  measure: Incidence of revision surgery at implant site
  time frame: Month 2, month 6, month 12 and month 24
  description: Rate of revision surgery at implant site will be analyzed and compared to the state of the art.
  intervention type: Device
  intervention name: Transforaminal lumbar interbody fusion
  description: Transforaminal Lumbar Interbody Fusion indicates a surgical approach in the lumbar spine to fuse the discal space between two vertebrae. These are joined by removing the disc and placing a cage in its place to restore the vertebral height. Screws and rods are also added to maintain the level secure while the bones fuse together.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Noel Graziani, Professor
  role: Principal Investigator
  affiliation: Hopital Privé Clairval
  last name: Renaud Duchenes
  phone: +33 6 86 16 61 91
  email: r.duchenes@spinevision.com
  last name: Hanta Ranaivoson
  email: h.ranaivoson@spinevision.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  investigator: 
  country: France
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Intervertebral Disc Degeneration
  sharing ipd: No