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

Description

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

Conditions

Microtia

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Study Overview

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Study Details

Study overview

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

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)

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

Condition
Microtia
Intervention / Treatment

-

Contacts and Locations

New York

Romo Plastic Surgery, New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • 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.

Ages Eligible for Study

8 Years to 29 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Auregen Biotherapeutics, SA,

Thomas Romo, III, MD, FACS, PRINCIPAL_INVESTIGATOR, Romo Plastic Surgery

Study Record Dates

2026-06