Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT04682418
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2019-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pedicle Screw Placement With XVS
Sponsor:
Augmedics
Organization:
Study Overview
Official Title:
Feasibility Study of Pedicle Screw Placement in the Spine With the XVISION SPINE System
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system.
Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score.
Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration.
Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score.
Surgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure
Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score.
Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration.
Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score.
Surgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: