drugset / Trial / NCT04399239
AuriNovo for Auricular Reconstruction
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-08-09
- Primary completion
- 2023-05-18
- Completion
- 2023-05-18
Outcome
Outcome not reported
Stopped: “Company decision, not safety related.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AuriNovo | Other / unclassified | — | Other |