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NCT07154667 · ClinicalTrials.gov registry record · NA
Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
A NA study of Microtia and Microtia-Anotia, sponsored by Nemours Children's Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07154667: Recruiting NA study of Microtia and Microtia-Anotia, sponsored by Nemours Children's Clinic.
NCT07154667 is a NA study of Microtia and Microtia-Anotia that is actively recruiting participants, run by Nemours Children's Clinic. The registered enrollment target is 30 participants, below the 1,626-participant average among 4 other Microtia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07154667, a NA study of Microtia and Microtia-Anotia, is actively recruiting participants, sponsored by Nemours Children's Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to improve surgical outcomes for children and young adults with ear differences severe secondary to congenital conditions (like microtia, a condition where the ear is underdeveloped), trauma (such as dog bites), or surgical resections secondary to skin cancer. The investigators have developed a novel medical device to shape cartilage into pre-determined shapes that, once assembled, assists the surgeon in creating an anatomically accurate cartilaginous ear framework, reduce surgery time, and minimize wire need. Other factors that might affect the quality of surgical outcomes will be examined in clinical trial participants.
Primary Outcome
Parents and patients (over age 12) will complete a four-question survey asking how much they like: the shape of the new ear, how the new ear looks, how natural the new ear looks, and the new ear overall. Participants will respond to each question with a rating from 1-5, with 1 being "do not like it at all" and 5 being "like it very much". Investigators will compare the responses from the hand-carved cohort and the AuryzoN™ EAR 2.0 cohort to determine which has more favorable outcomes.
Conditions Studied
Interventions
- PROCEDURE Use of AuryzoN™ EAR 2.0 device
- PROCEDURE Hand carving
Study Locations (1)
Florida
- Nemours Children's Hospital, Florida - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
What NCT07154667 shows while recruiting
NCT07154667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,626-participant average among 4 other Microtia trials with a reported enrollment target (98% lower).
The record links to 7 conditions, with Microtia appearing as the primary indexed condition, and to 2 interventions - of which Use of AuryzoN™ EAR 2.0 device is the first listed.
NCT07154667 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07154667 about?
NCT07154667 is a clinical study titled "Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction". This study aims to improve surgical outcomes for children and young adults with ear differences severe secondary to congenital conditions (like microtia, a condition where the ear is underdeveloped), trauma (such as dog bites), or surgical resections secondary to skin cancer. The investigators have ...
What is the current status of trial NCT07154667?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2025-10-01. Estimated completion is 2030-12-31.
What conditions does trial NCT07154667 study?
This clinical trial studies the following conditions: Microtia, Microtia-Anotia, Microtia, Congenital, Ear Deformities, Acquired, Ear Deformity External.
What interventions are being tested in trial NCT07154667?
The interventions under investigation include: Use of AuryzoN™ EAR 2.0 device (PROCEDURE), Hand carving (PROCEDURE).
Who is sponsoring clinical trial NCT07154667?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07154667 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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