Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311331
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-07
Brief Title:
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement PROCLAIM
Sponsor:
Restor3D
Organization:
Restor3D
Study Overview
Official Title:
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement PROCLAIM A Multicenter Single Arm Prospective Post-approval Study for Patients Who Received the restor3d TTR Device to Evaluate Safety and Probable Benefit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 is a Humanitarian Device Exemption HDE approved device The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None