<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/NCT03247166</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-36-17</org_study_id>
    <nct_id>NCT03247166</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System</brief_title>
  <official_title>A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</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 TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The&#xD;
      system is designed to afford motion of the spine segment without fusion. The pur0pose of this&#xD;
      prospective clinical study is to establish the safety and effectiveness of the TOPS™ System,&#xD;
      when used following decompression, in the treatment of lower back and sciatic pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Improvement</measure>
    <time_frame>24 months</time_frame>
    <description>Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Function Improvement</measure>
    <time_frame>24 months</time_frame>
    <description>Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fusion Prevention</measure>
    <time_frame>24 months</time_frame>
    <description>The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol</description>
  </primary_outcome>
  <other_outcome>
    <measure>Safety</measure>
    <time_frame>24 months</time_frame>
    <description>Subjects with no serious device complications as defined in the radiological protocol</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Lower Back Pain</condition>
  <arm_group>
    <arm_group_label>Lower Back and Leg Pain Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TOPS™ System</intervention_name>
    <description>The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the effected vertebrai level to alleviate pain stemming from degenerative joints</description>
    <arm_group_label>Lower Back and Leg Pain Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis&#xD;
&#xD;
          -  Patients with degenerative spondylolisthesis&#xD;
&#xD;
          -  Patients with at least 3 months failed conservative treatment&#xD;
&#xD;
          -  Narrowing of the lumbar spinal canal&#xD;
&#xD;
          -  Patients with lower back pain or sciatica&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Discogenic back pain at TOPS System level&#xD;
&#xD;
          -  Back or non-radicular leg pain of unknown etiology at TOPS System level&#xD;
&#xD;
          -  Lytic spondylolisthesis at TOPS System level&#xD;
&#xD;
          -  More than one motion segment involved in degenerative pathology to the extent that&#xD;
             justifies its inclusion in the surgical procedure&#xD;
&#xD;
          -  Known allergy to titanium and/or polyurethane&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eyal Behrbalk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ilana Alony, RN</last_name>
    <phone>972-4-6304487</phone>
    <email>ilanaa@hy.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>H̱adera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Ilana Alony, RN</last_name>
      <phone>972-4-6304487</phone>
      <email>ilanaa@hy.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</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>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03247166
org study id: HYMC-36-17
nct id: NCT03247166
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The
      system is designed to afford motion of the spine segment without fusion. The pur0pose of this
      prospective clinical study is to establish the safety and effectiveness of the TOPS™ System,
      when used following decompression, in the treatment of lower back and sciatic pain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Improvement
time frame: 24 months
description: Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
measure: Function Improvement
time frame: 24 months
description: Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
measure: Fusion Prevention
time frame: 24 months
description: The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol
measure: Safety
time frame: 24 months
description: Subjects with no serious device complications as defined in the radiological protocol
arm group label: Lower Back and Leg Pain Patients
arm group type: Experimental
description: Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System
intervention type: Device
intervention name: TOPS™ System
description: The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the effected vertebrai level to alleviate pain stemming from degenerative joints
arm group label: Lower Back and Leg Pain Patients
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Eyal Behrbalk, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Ilana Alony, RN
phone: 972-4-6304487
email: ilanaa@hy.health.gov.il
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Low Back Pain
sharing ipd: No