Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383611
Status:
AVAILABLE
Last Update Posted:
2024-04-25
First Post:
2024-04-19
Brief Title:
Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty
Sponsor:
Osteal Therapeutics Inc
Organization:
Osteal Therapeutics Inc
Study Overview
Official Title:
Protocol for Expanded Access to Cyclic Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Exchange Arthroplasty for Periprosthetic Joint Infection of the Hip or Knee
Status:
AVAILABLE
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:
APEX-EAP
Brief Summary:
The objective of the protocol is to provide access to the VT-X7 Vancomycin Tobramycin Exchanged in 7 Days system for subjects with periprosthetic joint infection PJI of the hip or knee who lack therapeutic treatment alternatives
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None