Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368700
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Brief Title:
The Hyalex Early Feasibility Study EFS
Sponsor:
Hyalex Orthopaedics Inc
Organization:
Hyalex Orthopaedics Inc
Study Overview
Official Title:
The Hyalex EFS A Prospective Multicenter Single-Arm 2-Phase Early Feasibility Study EFS of the HYALEX Knee Cartilage System
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The Hyalex Early Feasibility Study is a prospective multicenter open-label single-arm 2-phase early feasibility study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment will be enrolled in the study and undergo implantation of the HYALEX Knee Implant
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?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None