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

NCT06117267 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-11-07

No results posted yet for this 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.

Conditions

  • Cervical Spine Fusion

Interventions

DEVICE

Anatase Spine Surgery Navigation System

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

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Cheng-Di Chiu · China Medical University Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-09-30
Completion
2024-09-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06117267 on ClinicalTrials.gov