Status:
TERMINATED
Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201
Lead Sponsor:
Auregen Biotherapeutics, SA
Conditions:
Microtia
Eligibility:
All Genders
8-29 years
Phase:
PHASE1
PHASE2
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).
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 1\. Any condition which, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study.
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2025
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06078566
Start Date
January 26 2024
End Date
November 14 2025
Last Update
November 21 2025
Active Locations (1)
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1
Romo Plastic Surgery
New York, New York, United States, 10021