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

NCT ID: NCT06431698

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2025-07-31

Brief Summary

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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 EarWellâ„¢ group

Detailed Description

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Conditions

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Ear Malformation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Correction of deformation using the adjustable Earwell device

Group Type ACTIVE_COMPARATOR

adjustable Earwell device

Intervention Type DEVICE

Correction of deformation using the adjustable Earwell device

Intervention group

Correction of deformation using the custom-made silicone device

Group Type EXPERIMENTAL

Custom-made silicone device

Intervention Type DEVICE

Correction of deformation using the custom-made silicone device

Interventions

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Custom-made silicone device

Correction of deformation using the custom-made silicone device

Intervention Type DEVICE

adjustable Earwell device

Correction of deformation using the adjustable Earwell device

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital

Caen, N, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Alexis VEYSSIERE

Role: CONTACT

+33231063106 ext. +33

VEYSSIERE

Role: CONTACT

Facility Contacts

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Alexis VEYSSIERE, MD

Role: primary

Alexis VEYSSIERE

Role: backup

+33231063106 ext. +33

Other Identifiers

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21-0023

Identifier Type: -

Identifier Source: org_study_id

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