Ear MalformationMOLDEARNCT06431698
CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
A study testing Custom-made silicone device and adjustable Earwell device in people with Ear Malformation, run by University Hospital, Caen at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Ear Malformation
- What is being tested?
- Custom-made silicone device and adjustable Earwell device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2023to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn, age between 8 days and 1 month
- newborn with ear malformation
Who cannot join
- Total chondrocutaneous agenesis of the ear
- polymalformative syndrome
- age greater than 4 weeks
- parental refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
VEYSSIERE contact
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, N, 14000
Alexis VEYSSIERE, MD
Alexis VEYSSIERE, +33231063106 ext. +33, drci-secretariat@chu-caen.fr
About this study
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
- Being tested
- Custom-made silicone device, adjustable Earwell device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-made silicone deviceDevice
Correction of deformation using the custom-made silicone device
adjustable Earwell deviceDevice
Correction of deformation using the adjustable Earwell device
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Correction of deformation using the adjustable Earwell device Receives: Device: adjustable Earwell device |
| Intervention group | Experimental | Correction of deformation using the custom-made silicone device Receives: Device: Custom-made silicone device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 1 year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start31 Jul 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear MalformationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431698
- Sponsor's protocol ID
- 21-0023
- Acronym
- MOLDEAR
- Status last verified
- Jun 2026
- First submitted
- 22 May 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS
- ClinicalTrials.gov ID
- NCT06431698
- Acronym / sponsor ID
- MOLDEAR / 21-0023
- Conditions
- Ear Malformation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: adjustable Earwell deviceCorrection of deformation using the adjustable Earwell device |
| Intervention group | Experimental | Device: Custom-made silicone deviceCorrection of deformation using the custom-made silicone device |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborn, age between 8 days and 1 month
- newborn with ear malformation
Key exclusion criteria (4 listed)
- Total chondrocutaneous agenesis of the ear
- polymalformative syndrome
- age greater than 4 weeks
- parental refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom-made silicone deviceCorrection of deformation using the custom-made silicone device | Device | Intervention group |
| adjustable Earwell deviceCorrection of deformation using the adjustable Earwell device | Device | Control group |
Primary outcome
Subjective ear deformation score
Time frame: baseline and 1 year after
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
VEYSSIERE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-made silicone device and adjustable Earwell device in people with Ear Malformation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis VEYSSIERE (+33231063106 ext. +33, drci-secretariat@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective ear deformation score (time frame: baseline and 1 year after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.