Microtia Clinical Trial
Official title:
A Multicenter, Single Arm, Prospective, Open-Label, Staged Study of the Safety and Efficacy of the AuriNovo Construct for Auricular Reconstruction in Subjects With Unilateral Microtia
AuriNovo provides a patient-specific, biological construct for use in the surgical reconstruction of the external ear in people born with microtia Grades II-IV. This Phase 1 / 2A study is being conducted to collect preliminary safety data on microtic ear reconstruction using AuriNovo, fine-tune technical, logistical, surgical, and post-surgical care aspects related to implantation, and to gather preliminary efficacy data including short- and longer-term in vivo duration and biological status of the implant.
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