CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
MOLDEAR
1 other identifier
interventional
134
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2023
CompletedFirst Submitted
Initial submission to the registry
May 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedMay 28, 2024
March 1, 2024
1 year
May 22, 2024
May 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective ear deformation score
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.
baseline and 1 year after
Study Arms (2)
Control group
ACTIVE COMPARATORCorrection of deformation using the adjustable Earwell device
Intervention group
EXPERIMENTALCorrection of deformation using the custom-made silicone device
Interventions
Correction of deformation using the custom-made silicone device
Correction of deformation using the adjustable Earwell device
Eligibility Criteria
You may qualify if:
- Newborn, age between 8 days and 1 month
- newborn with ear malformation
You may not qualify if:
- Total chondrocutaneous agenesis of the ear
- polymalformative syndrome
- age greater than 4 weeks
- parental refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Caen University Hospital
Caen, N, 14000, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2024
First Posted
May 28, 2024
Study Start
July 31, 2023
Primary Completion
July 31, 2024
Study Completion
July 31, 2025
Last Updated
May 28, 2024
Record last verified: 2024-03