## Protocol Section
### Identification Module
**NCT ID:** NCT06431698

**Acronym:** MOLDEAR

**Brief Title:** CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS

**Official Title:** CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS

#### Organization Study ID Info
**ID:** 21-0023
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Caen
### Status Module
#### Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-07-31

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Caen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Ear Malformation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 134

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Correction of deformation using the adjustable Earwell device

**Intervention Names:**

- Device: adjustable Earwell device

**Label:** Control group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Correction of deformation using the custom-made silicone device

**Intervention Names:**

- Device: Custom-made silicone device

**Label:** Intervention group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention group

**Description:** Correction of deformation using the custom-made silicone device

**Name:** Custom-made silicone device

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** Correction of deformation using the adjustable Earwell device

**Name:** adjustable Earwell device

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Subjective ear deformation score

**Time Frame:** baseline and 1 year after

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 1 Month

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drci-secretariat@chu-caen.fr

**Name:** Alexis VEYSSIERE

**Phone:** +33231063106

**Phone Ext:** +33

**Role:** CONTACT

**Contact 2:**

**Email:** drci-secretariat@chu-caen.fr

**Name:** VEYSSIERE

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Caen

**Contacts:**

***Contact 1:***

- **Name:** Alexis VEYSSIERE, MD

- **Role:** CONTACT

***Contact 2:***

- **Email:** drci-secretariat@chu-caen.fr

- **Name:** Alexis VEYSSIERE

- **Phone:** +33231063106

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 3:***

- **Name:** Alexis VEYSSIERE, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Caen University Hospital

**State:** N

**Status:** RECRUITING

**Zip:** 14000

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12

- Name: Congenital Abnormalities

- Relevance: HIGH

- As Found: Deformity

### Condition Browse Module - Meshes

- ID: D000000013

- Term: Congenital Abnormalities

### Misc Info Module

- Version Holder: 2024-05-31
