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

NCT06431698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-05-28

No results posted yet for this study

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

Conditions

  • Ear Malformation

Interventions

DEVICE

Custom-made silicone device

Correction of deformation using the custom-made silicone device

DEVICE

adjustable Earwell device

Correction of deformation using the adjustable Earwell device

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2024-07-31
Completion
2025-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06431698 on ClinicalTrials.gov