CClinicalTrials.gg
Sign In
Not yet recruitingNCT06117267Updated Nov 7, 2023

Navigation Image Accuracy Test in Cervical Spine Surgery Using Anatase Spine Surgery Navigation System

An interventional study of Anatase Spine Surgery Navigation System in Cervical Spine Fusion, sponsored by China Medical University Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by China Medical University Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Cervical Spine Fusion

Keywords

  • Spine Surgery Navigation System
03

In context

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Anatase Spine Surgery Navigation System

    Using the navigation system during surgery

    Device: Anatase Spine Surgery Navigation System

Interventions

  • DeviceAnatase Spine Surgery Navigation System

    Collect images with the probe touching the target position before screw implantation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: during the surgery

  2. 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.

    Time frame: during the surgery

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06117267
Lead sponsor
China Medical University Hospital
Responsible party
Cheng-Di Chiu (Director, China Medical University Hospital) — Principal investigator
First posted
Nov 7, 2023
Start date
Nov 2023 (estimated)
Primary completion
Sep 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Nov 7, 2023

Study contacts

Cheng-Di Chiu
Contact
022459@tool.caaumed.org.tw
04-22052121 ext. 15033
Cheng-Di Chiu
principal investigator · China Medical University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

China Medical University Hospital

Start the discussion