RecruitingNot ApplicableNCT06431698

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

Sponsor

University Hospital, Caen

Enrollment

134 participants

Start Date

Jul 31, 2023

Study Type

INTERVENTIONAL

Conditions

Ear Malformation

Summary

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

Eligibility

Max Age: 1 Month

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Custom-made silicone device and adjustable Earwell device for people with ear malformation. The study is currently recruiting participants at 1 location. People eligible for this study include up to age 1 Month.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECustom-made silicone device

Correction of deformation using the custom-made silicone device

DEVICEadjustable Earwell device

Correction of deformation using the adjustable Earwell device

Locations(1)

Caen University Hospital

Caen, N, France

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NCT06431698

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