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/NCT06023719</url>
    </required_header>
    <id_info>
      <org_study_id>NEO-RA1-2023-01</org_study_id>
      <nct_id>NCT06023719</nct_id>
    </id_info>
    <brief_title>Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence</brief_title>
    <acronym>ACE-2</acronym>
    <official_title>Multicentric Clinical Investigation To Assess The Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NEOS Surgery</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NEOS Surgery</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 goal of this clinical investigation is to learn about DISC Care, an Hernia Blocking&#xD;
        System, in patients who have undergone lumbar disc hernia surgery. The main questions it aims&#xD;
        to answer are:&#xD;
  &#xD;
          -  if the implant (DISC Care) prevents disc herniation recurrence&#xD;
  &#xD;
          -  if DISC Care is a safe device&#xD;
  &#xD;
        Participants will be implanted with DISC Care and followed up for two years (7 visits).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2026</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of clinically symptomatic recurrent lumbar disc herniation</measure>
      <time_frame>24 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence and type of all adverse events (AE) and serious adverse events (SAE).</measure>
      <time_frame>6 weeks, 6 months, 12 months, and 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of clinically asymptomatic recurrent disc herniation</measure>
      <time_frame>6 months, 12 months, and 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of re-interventions</measure>
      <time_frame>6 weeks, 6 months, 12 months, and 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disc height maintenance [mm] related to baseline</measure>
      <time_frame>6 months, 12 months, and 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in leg and low back pain, related to baseline</measure>
      <time_frame>6 weeks, 6 months, 12 months, and 24 months</time_frame>
      <description>0-10 NRS (numeric rating scale)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Low back related disability, related to baseline</measure>
      <time_frame>6 weeks, 6 months, 12 months, and 24 months</time_frame>
      <description>Oswestry Disability Index (ODI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in quality of life, compared to baseline</measure>
      <time_frame>6 weeks, 6 months, 12 months, and 24 months</time_frame>
      <description>EQ-5D-5L (5-level EQ-5D version)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in patient neurological status, compared to baseline</measure>
      <time_frame>6 weeks, 6 months, 12 months, and 24 months</time_frame>
      <description>straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, classified as normal or abnormal</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The degeneration of the disc, in comparison with the preoperative state</measure>
      <time_frame>6 months, 12 months, and 24 months</time_frame>
      <description>Pfirrmann intervertebral disc degeneration scale (I, II, III, IV, V)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the direct and indirect costs of the disease and the intervention.</measure>
      <time_frame>6 weeks, 6 months, 12 months, and 24 months</time_frame>
      <description>Custom-made questionnaire</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Description of the impact of the procedure (implantation of the device) on the perioperative parameters</measure>
      <time_frame>Surgery</time_frame>
      <description>Blood loss (mL)</description>
    </other_outcome>
    <other_outcome>
      <measure>Description of the impact of the procedure (implantation of the device) on the perioperative parameters</measure>
      <time_frame>Surgery</time_frame>
      <description>X-ray exposition (seconds of x-ray exposition)</description>
    </other_outcome>
    <other_outcome>
      <measure>Description of the impact of the procedure (implantation of the device) on the perioperative parameters</measure>
      <time_frame>Surgery</time_frame>
      <description>Surgery duration (minutes)</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Disc Herniation</condition>
    <condition>Disk Herniated Lumbar</condition>
    <arm_group>
      <arm_group_label>DISC Care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>DISC Care implant</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>DISC Care</intervention_name>
      <description>Medical device to prevent disc herniation recurrence</description>
      <arm_group_label>DISC Care</arm_group_label>
      <other_name>Hernia Blocking System</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject is between 18 and 75 years old.&#xD;
  &#xD;
            -  Posterolateral disc hernia between levels L4 and S1 with radiological (CT scan or MRI)&#xD;
               confirmation of neural compression.&#xD;
  &#xD;
            -  At least six weeks of failed conservative treatment prior to surgery, including&#xD;
               physical therapy, use of anti-inflammatory medications at maximum specified dosage&#xD;
               and/or administration of epidural/facet injections.&#xD;
  &#xD;
            -  Minimum posterior disc height of 5 mm at the index level.&#xD;
  &#xD;
            -  Radiculopathy with positive straight leg raise test.&#xD;
  &#xD;
            -  ODI score of at least 30/100.&#xD;
  &#xD;
            -  Subjects who are able to give voluntary informed consent to participate in the&#xD;
               clinical investigation and from whom consent has been obtained.&#xD;
  &#xD;
            -  Subject is able and willing to comply with the protocol requirements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Spondylolisthesis and/or instability at the index level that, in the judgement of the&#xD;
               surgeon, could affect the device implantation.&#xD;
  &#xD;
            -  Central, foraminal or extraforaminal disc hernia.&#xD;
  &#xD;
            -  Subject has vertebral bodies of the index level affected by any traumatic, neoplastic,&#xD;
               metabolic, or infectious pathology.&#xD;
  &#xD;
            -  Subject has scoliosis of greater than 20 degrees (both angular and rotational).&#xD;
  &#xD;
            -  Grossly distorted anatomy due to congenital abnormalities.&#xD;
  &#xD;
            -  Deformation that affects the posterior corners of the vertebra at the index level&#xD;
               (e.g., osteophytes) that, in the judgment of the surgeon, could affect the device&#xD;
               implantation.&#xD;
  &#xD;
            -  Endplate irregularities that, in the judgment of the surgeon, could affect the device&#xD;
               implantation.&#xD;
  &#xD;
            -  Prior surgery at the index lumbar vertebral level that, in the judgment of the&#xD;
               surgeon, could affect the device implantation.&#xD;
  &#xD;
            -  Radiological confirmation of severe facet joint disease or degeneration.&#xD;
  &#xD;
            -  Patients diagnosed or at a high risk of osteoporosis (such as postmenopausal women and&#xD;
               patients receiving long-term treatment with corticosteroids) who present a bone&#xD;
               densitometry DXA (dual energy x-ray absorptiometry) T-score of less than -2.0 at the&#xD;
               index level.&#xD;
  &#xD;
            -  Cauda equina syndrome.&#xD;
  &#xD;
            -  Fever, leucocytosis and/or systemic or localized active infection.&#xD;
  &#xD;
            -  Systemic inflammation and/or inflammation at the implantation site.&#xD;
  &#xD;
            -  Any uncontrolled metabolic bone disease that affects the spine.&#xD;
  &#xD;
            -  Uncontrolled insulin-dependent diabetes mellitus.&#xD;
  &#xD;
            -  Peripheral neuropathy.&#xD;
  &#xD;
            -  Active hepatitis, AIDS or HIV.&#xD;
  &#xD;
            -  Rheumatoid arthritis or other autoimmune disease that affects the spine joints.&#xD;
  &#xD;
            -  Active or history of any invasive malignancy; patients with curatively-treated&#xD;
               malignancies who have been disease-free for at least 5 years are eligible.&#xD;
  &#xD;
            -  Uncontrolled active tuberculosis or history of uncontrolled tuberculosis in the past 3&#xD;
               years.&#xD;
  &#xD;
            -  Immunologically suppressed patients.&#xD;
  &#xD;
            -  Current anticoagulation therapy, unless anticoagulation therapy can be suspended for&#xD;
               surgery.&#xD;
  &#xD;
            -  Patients who have received medication (e.g., methotrexate, alendronate) that&#xD;
               interferes with bone mineral metabolism within 4 weeks of the planned date of the&#xD;
               index surgery.&#xD;
  &#xD;
            -  Suspected or known allergies or intolerance to the device materials: titanium,&#xD;
               nitinol, stainless steel, polyetheretherketone and polyethylene terephthalate.&#xD;
  &#xD;
            -  Any condition that precludes the use of general anaesthesia.&#xD;
  &#xD;
            -  Any condition that precludes the surgical procedure.&#xD;
  &#xD;
            -  Any contraindication for MRI or CT scan.&#xD;
  &#xD;
            -  Class III obesity: Body mass index ≥ 40.&#xD;
  &#xD;
            -  Current alcohol or recreational drug dependency.&#xD;
  &#xD;
            -  Pregnant or interested in becoming pregnant in the following 24 months.&#xD;
  &#xD;
            -  Breastfeeding.&#xD;
  &#xD;
            -  Life expectancy less than 2 years.&#xD;
  &#xD;
            -  Subject is currently participating or has participated in the previous 4 weeks in any&#xD;
               other interventional clinical study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Laia Rofes, PhD</last_name>
      <phone>+34 935944726</phone>
      <email>lrofes@neosurgery.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Daniel Alvarez, PhD</last_name>
      <phone>+34 935944726</phone>
      <email>dalvarez@neosurgery.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 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>Intervertebral Disc Displacement</mesh_term>
      <mesh_term>Recurrence</mesh_term>
      <mesh_term>Hernia</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/NCT06023719
  org study id: NEO-RA1-2023-01
  nct id: NCT06023719
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical investigation is to learn about DISC Care, an Hernia Blocking
        System, in patients who have undergone lumbar disc hernia surgery. The main questions it aims
        to answer are:
  
          -  if the implant (DISC Care) prevents disc herniation recurrence
  
          -  if DISC Care is a safe device
  
        Participants will be implanted with DISC Care and followed up for two years (7 visits).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Incidence of clinically symptomatic recurrent lumbar disc herniation
  time frame: 24 months
  measure: Incidence and type of all adverse events (AE) and serious adverse events (SAE).
  time frame: 6 weeks, 6 months, 12 months, and 24 months
  measure: Incidence of clinically asymptomatic recurrent disc herniation
  time frame: 6 months, 12 months, and 24 months
  measure: Incidence of re-interventions
  time frame: 6 weeks, 6 months, 12 months, and 24 months
  measure: Disc height maintenance [mm] related to baseline
  time frame: 6 months, 12 months, and 24 months
  measure: Change in leg and low back pain, related to baseline
  time frame: 6 weeks, 6 months, 12 months, and 24 months
  description: 0-10 NRS (numeric rating scale)
  measure: Change in Low back related disability, related to baseline
  time frame: 6 weeks, 6 months, 12 months, and 24 months
  description: Oswestry Disability Index (ODI)
  measure: The change in quality of life, compared to baseline
  time frame: 6 weeks, 6 months, 12 months, and 24 months
  description: EQ-5D-5L (5-level EQ-5D version)
  measure: The change in patient neurological status, compared to baseline
  time frame: 6 weeks, 6 months, 12 months, and 24 months
  description: straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, classified as normal or abnormal
  measure: The degeneration of the disc, in comparison with the preoperative state
  time frame: 6 months, 12 months, and 24 months
  description: Pfirrmann intervertebral disc degeneration scale (I, II, III, IV, V)
  measure: the direct and indirect costs of the disease and the intervention.
  time frame: 6 weeks, 6 months, 12 months, and 24 months
  description: Custom-made questionnaire
  measure: Description of the impact of the procedure (implantation of the device) on the perioperative parameters
  time frame: Surgery
  description: Blood loss (mL)
  measure: Description of the impact of the procedure (implantation of the device) on the perioperative parameters
  time frame: Surgery
  description: X-ray exposition (seconds of x-ray exposition)
  measure: Description of the impact of the procedure (implantation of the device) on the perioperative parameters
  time frame: Surgery
  description: Surgery duration (minutes)
  arm group label: DISC Care
  arm group type: Experimental
  description: DISC Care implant
  intervention type: Device
  intervention name: DISC Care
  description: Medical device to prevent disc herniation recurrence
  arm group label: DISC Care
  other name: Hernia Blocking System
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Laia Rofes, PhD
  phone: +34 935944726
  email: lrofes@neosurgery.com
  last name: Daniel Alvarez, PhD
  phone: +34 935944726
  email: dalvarez@neosurgery.com
  responsible party type: Sponsor
  mesh term: Intervertebral Disc Displacement
  mesh term: Recurrence
  mesh term: Hernia