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Recruiting NCT06431698

NCT06431698 CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS

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Clinical Trial Summary
NCT ID NCT06431698
Status Recruiting
Phase
Sponsor University Hospital, Caen
Condition Ear Malformation
Study Type INTERVENTIONAL
Enrollment 134 participants
Start Date 2023-07-31
Primary Completion 2027-07-31

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age 1 Month
Study Type INTERVENTIONAL
Interventions
Custom-made silicone deviceadjustable Earwell device

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 134 participants in total. It began in 2023-07-31 with a primary completion date of 2027-07-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

Inclusion Criteria: * Newborn, age between 8 days and 1 month * newborn with ear malformation Exclusion Criteria: * Total chondrocutaneous agenesis of the ear * polymalformative syndrome * age greater than 4 weeks * parental refusal

Contact & Investigator

Central Contact

Alexis VEYSSIERE

✉ drci-secretariat@chu-caen.fr

📞 +33231063106

Frequently Asked Questions

Who can join the NCT06431698 clinical trial?

This trial is open to participants of all sexes, up to 1 Month, studying Ear Malformation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06431698 currently recruiting?

Yes, NCT06431698 is actively recruiting participants. Contact the research team at drci-secretariat@chu-caen.fr for enrollment information.

Where is the NCT06431698 trial being conducted?

This trial is being conducted at Caen, France.

Who is sponsoring the NCT06431698 clinical trial?

NCT06431698 is sponsored by University Hospital, Caen. The trial plans to enroll 134 participants.

ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology