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
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Long-term follow-up of unilateral microtia patients implanted with AUR-201.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 29
Healthy Volunteers: f
View:
• Participated in Study AUR-201-05 and had the AUR-201 implant (auricle\* or auricle and wedge) in place at the Final Study Visit of Study AUR-201-05 (24 weeks after the first implantation surgery). \*If the Principal Investigator (PI) opted not to implant the wedge component beneath the auricle component and the subject has only the auricle in place at the Final Study Visit of Study AUR-201-05, the subject will be considered eligible under this inclusion criterion;
• Subject or guardian signed the informed consent form (ICF).
Locations
United States
New York
Romo Plastic Surgery
New York
Time Frame
Start Date: 2024-01-26
Completion Date: 2025-11-14
Participants
Target number of participants: 1
Treatments
Experimental: AUR-201
AUR-201
Related Therapeutic Areas
Sponsors
Leads: Auregen Biotherapeutics, SA