Spinal StenosisNCT04461964
Effects of a Spine Navigation System on Op-time and Radiation Exposure
A study testing Machine-vision Image Guided Surgery (MvIGS) spine navigation system. in people with Spinal Stenosis and Scoliosis, run by NYU Langone Health.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinal Stenosis, Scoliosis, Spondylolisthesis
- What is being tested?
- Machine-vision Image Guided Surgery (MvIGS) spine navigation system.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis, all grades, and planning to undergo surgical fusion;
- Skeletally mature adults between the ages of 18-85 years at the time of surgery;
- Has completed at least 6 months of conservative therapy for degenerative diagnosis, if appropriate; and,
- Personally signed and dated an informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the study.
Who cannot join
- History of malignancy, craniocervical junction pathology, cervical and thoracic locations, and/or previous lumbar operation;
- Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis;
- Significant peripheral vascular disease (defined as diminished dorsalis pedis or tibial pulses);
- Morbid obesity, defined as BMI > 40 kg/m2;
- Active systemic or local infection;
- Active hepatitis (defined as receiving medical treatment within two years);
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- Immunocompromised, such as but not limited to being diagnosed with Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, or Thymic Hypoplasia;
- Insulin-dependent diabetes mellitus or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
- Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months;
- History of Paget's disease, osteomalacia, or any other metabolic bone disease;
- Involved in study of another investigational product that may affect outcome;
- Women who are pregnant, lactating or anticipate becoming pregnant within 24 months post-surgery;
- Non-English speaking;
- Patients who are incarcerated;
- Worker's compensation cases; or,
- Patients involved in active litigation relating to his/her spinal condition.
About this study
Official title: Single Center, Prospective Study of the MvIGS Spine Navigation System in Posterior Fusion Utilizing Pedicle Screw Fixation
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.
Read the detailed description
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.
- Conditions
- Spinal Stenosis, Scoliosis, Spondylolisthesis
- Being tested
- Machine-vision Image Guided Surgery (MvIGS) spine navigation system.
- Medical subject headings
- Spinal Stenosis, Scoliosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine-vision Image Guided Surgery (MvIGS) spine navigation system.Device
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).
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | 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 Receives: Device: Machine-vision Image Guided Surgery (MvIGS) spine navigation system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total length of operative time
The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes.
Measured: Visit 1 Day 1
Secondary outcomes (8)
Length of time to register images
Aim: To reduce time for registration of reference images Measured: Seconds
Measured: Visit 1 Day 1
Length of time to place all screws
Aim: To reduce the time for screw placement Measured: Minutes
Measured: Visit 1 Day 1
Estimated blood loss (EBL)
Aim: To reduce the EBL of each case Measured: Millilitres (mL)
Measured: Visit 1 Day 1
Dose of intraoperative ionizing radiation
Aim: To reduce intraoperative ionizing radiation Measured: Total amount of the radiation dose in millisievert (mSv)
Measured: Visit 1 Day 1
Screw placement accuracy
Aim: To improve screw placement accuracy Measured: Graded using radiographic classification and clinical revision rate
Measured: Visit 1 Day 1
incidence of intraoperative complications
Aim: To decrease the incidence of intraoperative complications Measured: Number of reported complications
Measured: Visit 1 Day 1
Time to ambulation
Aim: To reduce time to ambulation Measured: Days
Measured: Post operative hospital visit (Day 1-10)
Time to hospital discharge after surgery
Aim: To reduce hospital length of stay Measured: Days
Measured: Post operative hospital visit (Day 1-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study startJul 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: funding for the study has stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- 7D Surgical Inc.
- Responsible party
- Sponsor
- Investigators
- Jeffrey A Goldstein, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461964
- Sponsor's protocol ID
- 19-01201
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2020
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Prospective Study of the MvIGS Spine Navigation System in Posterior Fusion Utilizing Pedicle Screw Fixation
- ClinicalTrials.gov ID
- NCT04461964
- Acronym / sponsor ID
- 19-01201
- Conditions
- Spinal Stenosis, Scoliosis, Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding for the study has stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- 7D Surgical Inc.
- Study start
- Jul 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: Machine-vision Image Guided Surgery (MvIGS) spine navigation system.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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis, all grades, and planning to undergo surgical fusion;
- Skeletally mature adults between the ages of 18-85 years at the time of surgery;
- Has completed at least 6 months of conservative therapy for degenerative diagnosis, if appropriate; and,
- Personally signed and dated an informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the study.
Key exclusion criteria (16 listed)
- History of malignancy, craniocervical junction pathology, cervical and thoracic locations, and/or previous lumbar operation;
- Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis;
- Significant peripheral vascular disease (defined as diminished dorsalis pedis or tibial pulses);
- Morbid obesity, defined as BMI > 40 kg/m2;
- Active systemic or local infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Machine-vision Image Guided Surgery (MvIGS) spine navigation system.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). | Device | treatment group |
Primary outcome
Total length of operative time
Time frame: Visit 1 Day 1
The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes.
8 secondary outcomes
Length of time to register images
Time frame: Visit 1 Day 1
Length of time to place all screws
Time frame: Visit 1 Day 1
Estimated blood loss (EBL)
Time frame: Visit 1 Day 1
Dose of intraoperative ionizing radiation
Time frame: Visit 1 Day 1
Screw placement accuracy
Time frame: Visit 1 Day 1
incidence of intraoperative complications
Time frame: Visit 1 Day 1
Time to ambulation
Time frame: Post operative hospital visit (Day 1-10)
Time to hospital discharge after surgery
Time frame: Post operative hospital visit (Day 1-10)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey A Goldstein, MD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A study testing Machine-vision Image Guided Surgery (MvIGS) spine navigation system. in people with Spinal Stenosis and Scoliosis, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total length of operative time (time frame: Visit 1 Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.