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New device could make ear reconstruction faster and more Natural-Looking for kids

NCT ID NCT07154667

Disease control Sponsor: Nemours Children's Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medical device that helps surgeons shape cartilage into a more natural-looking ear for children and young adults with missing or deformed ears due to birth defects, injuries, or cancer surgery. About 30 participants aged 5-20 will be enrolled. The goal is to see if the device leads to better-looking ears, shorter surgery times, and less wire use compared to the traditional hand-carving method.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 20 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged 5-20 years seeking to undergo surgical ear reconstruction or microtia repair under general anesthesia through NCH-FL * Pre-existing physical deformity of the ear necessitating surgical reconstruction * Patient of sufficient health to undergo surgery under general anesthesia * Parental or legally acceptable representative (LAR) permission obtained for inclusion in the study; patient assent obtained where age-appropriate * Sufficient fluency in English or Spanish to complete patient/parent surveys Exclusion Criteria: * Patients who will be ≤4 years old, or ≥21 years old at time of surgery * Patients with ear deformities do not require surgical correction * Patient's whose ear reconstruction surgery will be performed somewhere other than Nemours Children's Hospital - Florida * Patients determined to be in poor health to undergo surgery under general anesthesia * Parental or LAR permission cannot be obtained, and/or patient of sufficient age and cognitive capacity declines to assent * Lack of fluency in English or Spanish to complete patient/parent surveys

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Conditions

The condition(s) this trial relates to.

Ear Deformities, Acquired ear malformation microtia Microtia-Anotia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ear cartilage Ear deformities, acquired Ear deformity external Ear malformation Microtia Microtia, congenital Microtia-anotia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nemours Children's Hospital, Florida

    RECRUITING

    Orlando, Florida, 32827, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.