Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-26 @ 7:34 PM
Study NCT ID:
NCT06078566
Status:
TERMINATED
Last Update Posted:
2025-11-21
First Post:
2023-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201
Sponsor:
Auregen Biotherapeutics, SA
Organization:
Study Overview
Official Title:
Long-Term Follow-Up Study of Unilateral Microtia Patients Who Participated in Study AUR 201 05 and Had the AUR-201 Implant in Place at Final Visit (24 Weeks After the First Implantation Surgery)
Status:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AUR-201
Brief Summary:
Long-term follow-up of unilateral microtia patients implanted with AUR-201.
Detailed Description:
Long-term follow-up study of unilateral microtia patients who participated in Study AUR-201-05 and had the AUR-201 implant in place at the final visit (24 weeks post-implantation).
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?: