<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/NCT04461964</url>
  </required_header>
  <id_info>
    <org_study_id>19-01201</org_study_id>
    <nct_id>NCT04461964</nct_id>
  </id_info>
  <brief_title>Effects of a Spine Navigation System on Op-time and Radiation Exposure</brief_title>
  <official_title>Single Center, Prospective Study of the MvIGS Spine Navigation System in Posterior Fusion Utilizing Pedicle Screw Fixation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>7D Surgical Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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 study is to prospectively collect information about the operative time and&#xD;
      intraoperative radiation experienced by patients undergoing posterior spinal fusion&#xD;
      procedures guided by the MvIGS spine navigation system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, prospective case series to assess the use of the Machine-vision&#xD;
      Image Guided Surgery (MvIGS) spine navigation system for treatment of spinal stenosis,&#xD;
      scoliosis, and spondylolisthesis that requires fusion. This is a single-arm, open-label&#xD;
      study. All participants will undergo their single and multi-level posterior spine fusion&#xD;
      surgery using bilateral pedicle screw instrumentation under MvIGS intraoperative navigation&#xD;
      guidance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    funding for the study has stopped&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2022</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</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>Total length of operative time</measure>
    <time_frame>Visit 1 Day 1</time_frame>
    <description>The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of time to register images</measure>
    <time_frame>Visit 1 Day 1</time_frame>
    <description>Aim: To reduce time for registration of reference images Measured: Seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of time to place all screws</measure>
    <time_frame>Visit 1 Day 1</time_frame>
    <description>Aim: To reduce the time for screw placement Measured: Minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss (EBL)</measure>
    <time_frame>Visit 1 Day 1</time_frame>
    <description>Aim: To reduce the EBL of each case Measured: Millilitres (mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose of intraoperative ionizing radiation</measure>
    <time_frame>Visit 1 Day 1</time_frame>
    <description>Aim: To reduce intraoperative ionizing radiation Measured: Total amount of the radiation dose in millisievert (mSv)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screw placement accuracy</measure>
    <time_frame>Visit 1 Day 1</time_frame>
    <description>Aim: To improve screw placement accuracy Measured: Graded using radiographic classification and clinical revision rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of intraoperative complications</measure>
    <time_frame>Visit 1 Day 1</time_frame>
    <description>Aim: To decrease the incidence of intraoperative complications Measured: Number of reported complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to ambulation</measure>
    <time_frame>Post operative hospital visit (Day 1-10)</time_frame>
    <description>Aim: To reduce time to ambulation Measured: Days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to hospital discharge after surgery</measure>
    <time_frame>Post operative hospital visit (Day 1-10)</time_frame>
    <description>Aim: To reduce hospital length of stay Measured: Days</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Spinal Stenosis</condition>
  <condition>Scoliosis</condition>
  <condition>Spondylolisthesis</condition>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants will be identified by their treating physician and referred to the study research coordinator for enrollment. NYU standard practice in relation to pre-operative and intra-operative imaging studies will be explained. The role of the MvIGS system in this study will then also be explained. In each subject, they will perform posterior instrumentation utilizing the MvIGS spine navigation system for pedicle screw guidance and record data for intraoperative study endpoints</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Machine-vision Image Guided Surgery (MvIGS) spine navigation system.</intervention_name>
    <description>The intended use of the MvIGS navigation system is to provide high quality intraoperative imaging with no radiation exposure. Use of the proprietary integrated surgical light with embedded tracking technology and Flash™ registration allows for continuous and direct visualization of the surgical field. The MvIGS system is exempt from IDE regulations as the device cleared Premarket Notification FDA-510(k) (K162375). The device includes:&#xD;
A single mobile cart with a boom arm and an integrated surgical light with embedded tracking technology (P/N 10-0001);&#xD;
Proprietary imaging software (P/N 60-0007); and,&#xD;
Kit of tacked surgical instruments including a spine reference clamp, awl tip, pedicle probe (P/N 11-0006).</description>
    <arm_group_label>treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis,&#xD;
             all grades, and planning to undergo surgical fusion;&#xD;
&#xD;
          -  Skeletally mature adults between the ages of 18-85 years at the time of surgery;&#xD;
&#xD;
          -  Has completed at least 6 months of conservative therapy for degenerative diagnosis, if&#xD;
             appropriate; and,&#xD;
&#xD;
          -  Personally signed and dated an informed consent document prior to any study-related&#xD;
             procedures, indicating that the patient has been informed of all pertinent aspects of&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of malignancy, craniocervical junction pathology, cervical and thoracic&#xD;
             locations, and/or previous lumbar operation;&#xD;
&#xD;
          -  Significant peripheral neuropathy or acute denervation secondary to radiculopathy,&#xD;
             caused by conditions other than spinal stenosis;&#xD;
&#xD;
          -  Significant peripheral vascular disease (defined as diminished dorsalis pedis or&#xD;
             tibial pulses);&#xD;
&#xD;
          -  Morbid obesity, defined as BMI &gt; 40 kg/m2;&#xD;
&#xD;
          -  Active systemic or local infection;&#xD;
&#xD;
          -  Active hepatitis (defined as receiving medical treatment within two years);&#xD;
&#xD;
          -  Immunocompromised, such as but not limited to being diagnosed with Acquired&#xD;
             Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency&#xD;
             Syndrome, or Thymic Hypoplasia;&#xD;
&#xD;
          -  Insulin-dependent diabetes mellitus or any other medical condition(s) that would&#xD;
             represent a significant increase in surgical risk or interfere with normal healing;&#xD;
&#xD;
          -  Immunologically suppressed, or has received systemic steroids, excluding nasal&#xD;
             steroids, at any dose daily for &gt; 1 month within last 12 months;&#xD;
&#xD;
          -  History of Paget's disease, osteomalacia, or any other metabolic bone disease;&#xD;
&#xD;
          -  Involved in study of another investigational product that may affect outcome;&#xD;
&#xD;
          -  Women who are pregnant, lactating or anticipate becoming pregnant within 24 months&#xD;
             post-surgery;&#xD;
&#xD;
          -  Non-English speaking;&#xD;
&#xD;
          -  Patients who are incarcerated;&#xD;
&#xD;
          -  Worker's compensation cases; or,&#xD;
&#xD;
          -  Patients involved in active litigation relating to his/her spinal condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey A Goldstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>June 8, 2022</last_update_submitted>
  <last_update_submitted_qc>June 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2022</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>Scoliosis</mesh_term>
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_access_criteria>The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Jeffrey.goldstein@nyulangone.org . To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT04461964
org study id: 19-01201
nct id: NCT04461964
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to prospectively collect information about the operative time and
      intraoperative radiation experienced by patients undergoing posterior spinal fusion
      procedures guided by the MvIGS spine navigation system.
This is a single-center, prospective case series to assess the use of the Machine-vision
      Image Guided Surgery (MvIGS) spine navigation system for treatment of spinal stenosis,
      scoliosis, and spondylolisthesis that requires fusion. This is a single-arm, open-label
      study. All participants will undergo their single and multi-level posterior spine fusion
      surgery using bilateral pedicle screw instrumentation under MvIGS intraoperative navigation
      guidance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total length of operative time
time frame: Visit 1 Day 1
description: The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes.
measure: Length of time to register images
time frame: Visit 1 Day 1
description: Aim: To reduce time for registration of reference images Measured: Seconds
measure: Length of time to place all screws
time frame: Visit 1 Day 1
description: Aim: To reduce the time for screw placement Measured: Minutes
measure: Estimated blood loss (EBL)
time frame: Visit 1 Day 1
description: Aim: To reduce the EBL of each case Measured: Millilitres (mL)
measure: Dose of intraoperative ionizing radiation
time frame: Visit 1 Day 1
description: Aim: To reduce intraoperative ionizing radiation Measured: Total amount of the radiation dose in millisievert (mSv)
measure: Screw placement accuracy
time frame: Visit 1 Day 1
description: Aim: To improve screw placement accuracy Measured: Graded using radiographic classification and clinical revision rate
measure: incidence of intraoperative complications
time frame: Visit 1 Day 1
description: Aim: To decrease the incidence of intraoperative complications Measured: Number of reported complications
measure: Time to ambulation
time frame: Post operative hospital visit (Day 1-10)
description: Aim: To reduce time to ambulation Measured: Days
measure: Time to hospital discharge after surgery
time frame: Post operative hospital visit (Day 1-10)
description: Aim: To reduce hospital length of stay Measured: Days
arm group label: treatment group
arm group type: Experimental
description: Eligible participants will be identified by their treating physician and referred to the study research coordinator for enrollment. NYU standard practice in relation to pre-operative and intra-operative imaging studies will be explained. The role of the MvIGS system in this study will then also be explained. In each subject, they will perform posterior instrumentation utilizing the MvIGS spine navigation system for pedicle screw guidance and record data for intraoperative study endpoints
intervention type: Device
intervention name: Machine-vision Image Guided Surgery (MvIGS) spine navigation system.
description: The intended use of the MvIGS navigation system is to provide high quality intraoperative imaging with no radiation exposure. Use of the proprietary integrated surgical light with embedded tracking technology and Flash™ registration allows for continuous and direct visualization of the surgical field. The MvIGS system is exempt from IDE regulations as the device cleared Premarket Notification FDA-510(k) (K162375). The device includes:
A single mobile cart with a boom arm and an integrated surgical light with embedded tracking technology (P/N 10-0001);
Proprietary imaging software (P/N 60-0007); and,
Kit of tacked surgical instruments including a spine reference clamp, awl tip, pedicle probe (P/N 11-0006).
arm group label: treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jeffrey A Goldstein, MD
role: Principal Investigator
affiliation: NYU Langone Health
responsible party type: Sponsor
mesh term: Scoliosis
mesh term: Spinal Stenosis
mesh term: Spondylolisthesis
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd access criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Jeffrey.goldstein@nyulangone.org . To gain access, data requestors will need to sign a data access agreement.