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Recruiting

NCT Number: NCT06431698

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

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

Recruiting

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Key information

Conditions

Ear Malformation

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, N, 14000, France

Location status: Recruiting

Location contact

Alexis VEYSSIERE

CONTACT

[email protected]

+33231063106 ext. +33

Alexis VEYSSIERE, MD

CONTACT

Alexis VEYSSIERE, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custom-made silicone device

Device

Correction of deformation using the custom-made silicone device

adjustable Earwell device

Device

Correction of deformation using the adjustable Earwell device

Primary outcomes

  1. Subjective ear deformation score

    Time frame: baseline and 1 year after

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis VEYSSIERE

CONTACT

[email protected]

+33231063106 ext. +33

VEYSSIERE

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: MOLDEAR

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 28, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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