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/NCT05971329</url>
    </required_header>
    <id_info>
      <org_study_id>ZG-2022-003</org_study_id>
      <nct_id>NCT05971329</nct_id>
    </id_info>
    <brief_title>Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease</brief_title>
    <official_title>Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zetagen Therapeutics, Inc</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zetagen Therapeutics, Inc</source>
    <oversight_info>
      <has_dmc>Yes</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 pilot clinical trial is to test the safety and preliminary performance of&#xD;
        the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain&#xD;
        or loss of neurological function.&#xD;
  &#xD;
        Participants will be treated with ZetaFuse during surgical intervention to reduce pain and&#xD;
        the loss of neurological function.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>Early Phase 1</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>Subjects with Radiologic Determination of Bone Fusion of the Treated Cervical Vertebral Bones</measure>
      <time_frame>1 year post surgery</time_frame>
      <description>Radiological Fusion of the cervical vertebral bones, assessed using planar X-radiographs or computed tomography. Fusion is defined as continuous bridging bone between the endplates of the operated cervical vertebral bones. Subjects with fusion will be assessed as having a successful outcome while subjects without fusion will have failed the procedure.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of Life via Short Form (SF12v2) Health Survey</measure>
      <time_frame>1 year post surgery</time_frame>
      <description>SF12 measures quality of life, pain, and activity in a survey using 12 questions, with scores &gt;50 showing a better outcome</description>
    </secondary_outcome>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Radiculopathy, Cervical</condition>
    <condition>Myelopathy Cervical</condition>
    <condition>Neurological Abnormality</condition>
    <condition>Disc Disease</condition>
    <condition>Disc Degeneration</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cervical Fusion (ZetaFuse™ Bone Graft)</intervention_name>
      <description>Fusion of the C3-C7 cervical vertebral bodies</description>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 22 to 75 years (inclusive) at the time of enrollment.&#xD;
  &#xD;
            2. Diagnosis of radiculopathy and/or myelopathy of the cervical spine, with pain,&#xD;
               paresthesias or paralysis in a specific nerve root distribution C3 through C7,&#xD;
               including at least one of the following:&#xD;
  &#xD;
                 -  Neck and/or arm pain (at least 3 on the 0 - 10 numeric rating scale for pain.&#xD;
  &#xD;
                 -  Decreased muscle strength of at least one level on the clinical evaluation 0 to 5&#xD;
                    scale.&#xD;
  &#xD;
                 -  Abnormal sensation including hyperesthesia or hypoesthesia. and/or&#xD;
  &#xD;
                 -  Abnormal reflexes.&#xD;
  &#xD;
            3. Symptomatic at two contiguous levels from C3 to C7.&#xD;
  &#xD;
            4. Radiographically determined pathology at the level to be treated correlating to&#xD;
               primary symptoms including at least one of the following:&#xD;
  &#xD;
                 -  Decreased disc height on radiography, computed tomography (CT), or magnetic&#xD;
                    resonance imaging (MRI) in comparison to a normal adjacent disc.&#xD;
  &#xD;
                 -  Degenerative spondylosis on CT or MRI.&#xD;
  &#xD;
                 -  Disc herniation on CT or MRI.&#xD;
  &#xD;
            5. Neck Disability Index Score ≥ 30/100.&#xD;
  &#xD;
            6. Unresponsive to non-operative treatment (e.g., rest, heat, physical therapy,&#xD;
               chiropractor, massage, pain medication) for approximately six weeks from the symptom&#xD;
               onset; or has the presence of progressive symptoms or signs of nerve root/spinal cord&#xD;
               compression in the face of continued non-operative management.&#xD;
  &#xD;
            7. No previous surgical intervention at the involved levels or any subsequent,&#xD;
               planned/staged surgical procedure at the involved or adjacent levels.&#xD;
  &#xD;
            8. Appropriate for treatment using an anterior surgical approach.&#xD;
  &#xD;
            9. Skeletally mature at the time of the surgery.&#xD;
  &#xD;
           10. Medically cleared for surgery.&#xD;
  &#xD;
           11. If a female of child-bearing potential, subject is non-pregnant, nonnursing, and&#xD;
               agrees not to become pregnant during the study period.&#xD;
  &#xD;
           12. Willing and able to comply with the study plan.&#xD;
  &#xD;
           13. Signed written Patient Informed Consent Form.&#xD;
  &#xD;
           14. Willing to discontinue use of non-steroidal anti-inflammatory drugs (NSAIDs) from one&#xD;
               week before the surgery to 3 months after the surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. A cervical spinal condition other than symptomatic cervical degenerative disc disease&#xD;
               requiring surgical treatment at the involved levels.&#xD;
  &#xD;
            2. Documented or diagnosed cervical instability relative to adjacent segments at either&#xD;
               level, defined by dynamic (flexion/extension) radiographs showing sagittal plane&#xD;
               translation &gt;3.5 mm or sagittal plane angulation &gt; 20°.&#xD;
  &#xD;
            3. More than two cervical levels requiring surgical treatment.&#xD;
  &#xD;
            4. An immobile or spontaneously fused level adjacent to the levels to be treated.&#xD;
  &#xD;
            5. Severe pathology of the facet joints of the involved vertebral bodies.&#xD;
  &#xD;
            6. Previous surgical intervention at either one or both of the involved levels or at&#xD;
               adjacent levels.&#xD;
  &#xD;
            7. History of trauma to the C3 to C7 levels resulting in significant bony or&#xD;
               disco-ligamentous cervical spine injury.&#xD;
  &#xD;
            8. Previously diagnosed with osteomalacia;&#xD;
  &#xD;
            9. Any of the following that may be associated with an increased risk osteoporosis (if&#xD;
               &quot;Yes&quot; to any of the below risk factors, a DEXA Scan is required to determine&#xD;
               eligibility). If the level of bone mineral density (BMD) on DEXA scan is a T score of&#xD;
               -2.5 or worse (i.e., -2.6, - 2.7, etc.) the subject is ineligible for the study.&#xD;
  &#xD;
                 -  Postmenopausal non-Black female over 60 years of age who weighs less than 140&#xD;
                    pounds.&#xD;
  &#xD;
                 -  Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist&#xD;
                    fracture.&#xD;
  &#xD;
                 -  Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.&#xD;
  &#xD;
                 -  Taking bisphosphonate medication for the treatment of osteoporosis.&#xD;
  &#xD;
                 -  Chronic use of high dose steroids.&#xD;
  &#xD;
           10. Reported active malignancy that included a history of any invasive malignancy (except&#xD;
               non-melanoma skin cancer) unless the subject had been treated with curative intent and&#xD;
               there had been no clinical signs or symptoms of the malignancy for at least five&#xD;
               years.&#xD;
  &#xD;
           11. Overt or active systemic infection, or infection at the operative site.&#xD;
  &#xD;
           12. Insulin dependent diabetes.&#xD;
  &#xD;
           13. A tobacco user who does not agree to suspend smoking prior to surgery.&#xD;
  &#xD;
           14. Chronic or acute renal failure or prior history of renal disease.&#xD;
  &#xD;
           15. Mentally incompetent (If questionable, obtain psychiatric consult).&#xD;
  &#xD;
           16. A prisoner.&#xD;
  &#xD;
           17. An alcohol and/or drug abuser currently or recently undergoing treatment for alcohol&#xD;
               and/or drug abuse.&#xD;
  &#xD;
           18. Involved with current or pending litigation regarding a spinal condition.&#xD;
  &#xD;
           19. Received drugs that may interfere with bone metabolism within two weeks prior to the&#xD;
               planned date of spinal surgery (e.g., steroids or methotrexate) excluding routine&#xD;
               perioperative anti-inflammatory drugs.&#xD;
  &#xD;
           20. A history of an endocrine or metabolic disorder known to affect osteogenesis (e.g.,&#xD;
               Paget's Disease, renal osteodystrophy, Ehlers- Danlos Syndrome, or osteogenesis&#xD;
               imperfecta).&#xD;
  &#xD;
           21. A condition that requires post-operative medications that interfere with the stability&#xD;
               of the implant, such as steroids. (This does not include low dose aspirin for&#xD;
               prophylactic anticoagulation and routine perioperative anti-inflammatory drugs).&#xD;
  &#xD;
           22. Received treatment with an investigational therapy within 28 days prior to&#xD;
               implantation surgery or such treatment is planned during the 16 weeks following&#xD;
               implantation with the ZetaFuse™ Bone Graft device.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>Spinal Diseases</mesh_term>
      <mesh_term>Intervertebral Disc Degeneration</mesh_term>
      <mesh_term>Radiculopathy</mesh_term>
      <mesh_term>Spinal Cord Diseases</mesh_term>
      <mesh_term>Nervous System Malformations</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/NCT05971329
  org study id: ZG-2022-003
  nct id: NCT05971329
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this pilot clinical trial is to test the safety and preliminary performance of
        the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain
        or loss of neurological function.
  
        Participants will be treated with ZetaFuse during surgical intervention to reduce pain and
        the loss of neurological function.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Subjects with Radiologic Determination of Bone Fusion of the Treated Cervical Vertebral Bones
  time frame: 1 year post surgery
  description: Radiological Fusion of the cervical vertebral bones, assessed using planar X-radiographs or computed tomography. Fusion is defined as continuous bridging bone between the endplates of the operated cervical vertebral bones. Subjects with fusion will be assessed as having a successful outcome while subjects without fusion will have failed the procedure.
  measure: Quality of Life via Short Form (SF12v2) Health Survey
  time frame: 1 year post surgery
  description: SF12 measures quality of life, pain, and activity in a survey using 12 questions, with scores >50 showing a better outcome
  intervention type: Device
  intervention name: Cervical Fusion (ZetaFuse™ Bone Graft)
  description: Fusion of the C3-C7 cervical vertebral bodies
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor
  mesh term: Spinal Diseases
  mesh term: Intervertebral Disc Degeneration
  mesh term: Radiculopathy
  mesh term: Spinal Cord Diseases
  mesh term: Nervous System Malformations
  sharing ipd: No