Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-01 @ 10:04 AM
Study NCT ID:
NCT04860635
Status:
SUSPENDED
Last Update Posted:
2025-11-26
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of F14 Following Total Knee Replacement
Sponsor:
Arthritis Innovation Corporation
Organization:
Study Overview
Official Title:
An Open Label Safety Study of a Single Administration of F14 in Patients Undergoing Unilateral Total Knee Replacement
Status:
SUSPENDED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study superseded by alternative Phase 3 trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: