TerminatedPhase 1/2

Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201

Stopped: Business reasons

United States1 participantsStarted 2024-01-26

Plain-language summary

Long-term follow-up of unilateral microtia patients implanted with AUR-201.

Age range8 Years – 29 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

Appearance/Long-Term Durability of the AUR-201 Implant

Timeframe: 72 weeks. The study starts at 24 weeks post implantation and ends at 96 weeks post implantation for a total of 72 weeks for this study.

Incidence of Long Term Treatment-Emergent Adverse Events

Timeframe: 72 weeks. The study starts at 24 weeks post implantation and ends at 96 weeks post implantation for a total of 72 weeks for this study

NCT IDNCT06078566

SponsorAuregen Biotherapeutics, SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-14