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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 EarWell™ group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Correction of deformation using the adjustable Earwell device |
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| Intervention group | Experimental | Correction of deformation using the custom-made silicone device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom-made silicone device | Device | Correction of deformation using the custom-made silicone device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexis VEYSSIERE | Contact | +33231063106 | +33 | drci-secretariat@chu-caen.fr |
| VEYSSIERE | Contact | drci-secretariat@chu-caen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Recruiting | Caen | N | 14000 | France |
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| adjustable Earwell device | Device | Correction of deformation using the adjustable Earwell device |
|