Cervical Spine FusionNCT06117267
Navigation Image Accuracy Test in Cervical Spine Surgery Using Anatase Spine Surgery Navigation System
A study testing Anatase Spine Surgery Navigation System in people with Cervical Spine Fusion, run by China Medical University Hospital.
Trial summary
The "Anatase" Spine Surgery Navigation System used in this study has obtained market approval in Taiwan(MOHW-MD-No.006663) and the United States (510(k) Numbers: K180523 and K220348). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Spine Fusion
- What is being tested?
- Anatase Spine Surgery Navigation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to 30 Sep 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤70 years
- Patients who need to undergo posterior cervical pedicle screw placement surgery
- The subject is willing to provide preoperative CT images and to use the navigation system during surgery for the verification of navigation image accuracy.
- Subjects are willing and able to comply with the procedures and requirements of this clinical trial.
- Subjects are able to understand and willing to sign the informed consent form.
Who cannot join
- Creutzfeldt-Jakob disease
- Known allergy to stainless steel
- Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia
- Pregnant women
- Have a systematic or local infection, which may increase study risk
- Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
Show all 12Show fewer
- Use of anticoagulants
- Osteoporosis
- Be on uncontrolled diabetes mellitus.
- Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months.
- Previous history of cervical spine surgery
- Other medical conditions, as judged by a physician, may affect the physiological status for surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-arm, Single-center Clinical Study to Verify the Navigation Image Accuracy in Cervical Spine Surgery Using Anatase Spine Surgery Navigation System
The "Anatase" Spine Surgery Navigation System used in this study has obtained market approval in Taiwan(MOHW-MD-No.006663) and the United States (510(k) Numbers: K180523 and K220348).
The "Anatase" Spine Surgery Navigation System, also known as an Image Guide System, is indicated for precise positioning of surgical instruments or spinal implants, such as pedicle screw placement, during general spinal surgery. The system uses wireless optical tracking technology to track the position of instruments in relation to the surgical anatomy and register to the relative position in preoperative 3D CT imagery.
The aim of the study is to verify the accuracy of "Anatase" Spine Surgery Navigation System in Image-guided Cervical Spine Surgery. This trial will involve 8 subjects using the approved "Anatase" Spine Surgery Navigation System to collect images before screw implantation, and verify the accuracy of navigation images in cervical spine surgery.
Read the detailed description
The "Anatase" Spine Surgery Navigation System, is composed of an Optical Tracker, Computer, No-Touch Reader and Dynamic Reference Frame (DRF). The Optical Tracker is a position sensor, it tracks the position of instruments with DRF by infrared light, allowing the instrument and vertebra to be positioned. The Computer is a touch screen panel PC running the proprietary spine NAVI software that guides the surgical procedure and display the results of the operation and computation. A No-Touch Reader, which attached on the Optical Tracker, is a no-touch sensor to identify instruments. It's a unique design and identification technology allows the instrument to be wirelessly identified, reducing the risk and time required to set up the instrument type. The system can track the position of patient's vertebra and instruments by mounting the DRF on patient's vertebra and instruments.
The "Anatase" Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. The system helps to guide surgeons with real-time image and provides preoperative planning and intraoperative control.
- Conditions
- Cervical Spine Fusion
- Being tested
- Anatase Spine Surgery Navigation System
- Keywords
- Spine Surgery Navigation System
- Medical subject headings
- Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatase Spine Surgery Navigation SystemDevice
Collect images with the probe touching the target position before screw implantation
| Study group | Role | What they receive |
|---|---|---|
| Anatase Spine Surgery Navigation System | Experimental | Using the navigation system during surgery Receives: Device: Anatase Spine Surgery Navigation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the actual and virtual (navigation system) distance of the probe.
The assessor will measure the distance (mm) of the probe between the actual and virtual (navigation system) images.
Measured: during the surgery
Difference between the actual and virtual (navigation system) angle of the probe.
The assessor will measure the angle (°) of the probe between the actual and virtual (navigation system) images.
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study startNov 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine FusionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Di Chiu, China Medical University Hospital
- Investigators
- Cheng-Di Chiu, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117267
- Sponsor's protocol ID
- CMUH112-REC1-144
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center Clinical Study to Verify the Navigation Image Accuracy in Cervical Spine Surgery Using Anatase Spine Surgery Navigation System
- ClinicalTrials.gov ID
- NCT06117267
- Acronym / sponsor ID
- CMUH112-REC1-144
- Conditions
- Cervical Spine Fusion
- Keywords
- Spine Surgery Navigation System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 7 Nov 2023 (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 "Anatase" Spine Surgery Navigation System used in this study has obtained market approval in Taiwan(MOHW-MD-No.006663) and the United States (510(k) Numbers: K180523 and K220348).
The "Anatase" Spine Surgery Navigation System, also known as an Image Guide System, is indicated for precise positioning of surgical instruments or spinal implants, such as pedicle screw placement, during general spinal surgery. The system uses wireless optical tracking technology to track the position of instruments in relation to the surgical anatomy and register to the relative position in preoperative 3D CT imagery.
The aim of the study is to verify the accuracy of "Anatase" Spine Surgery Navigation System in Image-guided Cervical Spine Surgery. This trial will involve 8 subjects using the approved "Anatase" Spine Surgery Navigation System to collect images before screw implantation, and verify the accuracy of navigation images in cervical spine surgery.
Detailed description
The "Anatase" Spine Surgery Navigation System, is composed of an Optical Tracker, Computer, No-Touch Reader and Dynamic Reference Frame (DRF). The Optical Tracker is a position sensor, it tracks the position of instruments with DRF by infrared light, allowing the instrument and vertebra to be positioned. The Computer is a touch screen panel PC running the proprietary spine NAVI software that guides the surgical procedure and display the results of the operation and computation. A No-Touch Reader, which attached on the Optical Tracker, is a no-touch sensor to identify instruments. It's a unique design and identification technology allows the instrument to be wirelessly identified, reducing the risk and time required to set up the instrument type. The system can track the position of patient's vertebra and instruments by mounting the DRF on patient's vertebra and instruments.
The "Anatase" Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. The system helps to guide surgeons with real-time image and provides preoperative planning and intraoperative control.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anatase Spine Surgery Navigation System | Experimental | Device: Anatase Spine Surgery Navigation SystemUsing the navigation system during surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years and ≤70 years
- Patients who need to undergo posterior cervical pedicle screw placement surgery
- The subject is willing to provide preoperative CT images and to use the navigation system during surgery for the verification of navigation image accuracy.
- Subjects are willing and able to comply with the procedures and requirements of this clinical trial.
- Subjects are able to understand and willing to sign the informed consent form.
Key exclusion criteria (12 listed)
- Creutzfeldt-Jakob disease
- Known allergy to stainless steel
- Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia
- Pregnant women
- Have a systematic or local infection, which may increase study risk
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 |
|---|---|---|
| Anatase Spine Surgery Navigation SystemCollect images with the probe touching the target position before screw implantation | Device | Anatase Spine Surgery Navigation System |
Primary outcome
Difference between the actual and virtual (navigation system) distance of the probe.
Time frame: during the surgery
The assessor will measure the distance (mm) of the probe between the actual and virtual (navigation system) images.
Difference between the actual and virtual (navigation system) angle of the probe.
Time frame: during the surgery
The assessor will measure the angle (°) of the probe between the actual and virtual (navigation system) images.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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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.
Cheng-Di Chiu principal investigator
China Medical University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Anatase Spine Surgery Navigation System in people with Cervical Spine Fusion, run by China Medical University Hospital.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Di Chiu (04-22052121 ext. 15033, 022459@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the actual and virtual (navigation system) distance of the probe. (time frame: during the surgery). The study lists 2 primary outcomes in all. 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 7 Nov 2023.