Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-27
Brief Title:
Navigation Image Accuracy Test in Cervical Spine Surgery Using Anatase Spine Surgery Navigation System
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Anatase Spine Surgery Navigation System used in this study has obtained market approval in TaiwanMOHW-MD-No006663 and the United States 510k 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
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 Its 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 patients vertebra and instruments by mounting the DRF on patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None