CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS

Recruiting now · Not applicable

Conditions studied: Ear Malformation

In brief

Evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of Caen University Hospital compared to the device from the EarWell™ group

Key facts

Study ID

NCT06431698

Run by

University Hospital, Caen

People needed

134

Starts

2023-07-31

Expected to finish

2028-07-31

Last updated by the study team

2026-06-25

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newborn, age between 8 days and 1 month
• newborn with ear malformation

You may not qualify if…

• Total chondrocutaneous agenesis of the ear
• polymalformative syndrome
• age greater than 4 weeks
• parental refusal

Where it is running

• Caen University Hospital — Caen, N, France (enrolling)

Full record on ClinicalTrials.gov

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