Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261242
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-07
Brief Title:
Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
A Study of Tripod-Fix Vertebral Body Augmentation System in Vertebral Compression Fractures Caused by Osteoporosis
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This study is to evaluate the safety and effectiveness of the Tripod-Fix with Tecres Mendec Spine HV System to treat subjects with osteoporotic vertebral compression fractures
Detailed Description:
This study is a prospective single-center open-label single-arm study This study will screen up to 12 eligible patients Eligible patients will be treated with Tripod-Fix on the Day 1 and follow-up for 12 months Patients will be asked to return to the study site for assessments on the Day 5 1st month 6th month and 12th month Safety will be assessed by the investigators at each return visit and will be monitored until the end of the study
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?:
None