Long-term follow-up for patients with unilateral microtia who received AUR-201 implants
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)
PHASE1; PHASE2 · Auregen Biotherapeutics, SA · NCT06078566
This study looks at how well the AUR-201 implant works and its safety over time for people with one-sided microtia who have already received the implant.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 8 Years to 29 Years |
| Sex | All |
| Sponsor | Auregen Biotherapeutics, SA (industry) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06078566 on ClinicalTrials.gov |
What this trial studies
This study focuses on the long-term follow-up of patients with unilateral microtia who have been implanted with AUR-201. It aims to assess the outcomes and safety of the AUR-201 implant over an extended period following the initial implantation. Participants must have completed a previous study (AUR-201-05) and have the implant in place at the final visit. The study will involve monitoring the patients to gather data on the effectiveness and durability of the implant.
Who should consider this trial
Good fit: Ideal candidates are individuals who participated in the AUR-201-05 study and had the AUR-201 implant in place at the final visit.
Not a fit: Patients who did not participate in the AUR-201-05 study or do not have the AUR-201 implant in place will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of AUR-201 implants for patients with microtia.
How similar studies have performed: While this study builds on previous research involving AUR-201, the long-term follow-up aspect may provide novel insights into its sustained effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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; 2. Subject or guardian signed the informed consent form (ICF). Exclusion Criteria: 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.
Where this trial is running
New York, New York
- Romo Plastic Surgery — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Thomas Romo, III, MD, FACS — Romo Plastic Surgery
- Study coordinator: Michelle Nelken
- Email: mnelken@auregen.bio
- Phone: 6177554149
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Microtia