Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-17

Study Completion Date

2021-09-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an open-label, prospective, uncontrolled, single arm, post-marketing study of the long-term safety and performance of EARFOLD® Implantable Clip System.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia

NCT06072040

Microtia

TERMINATED PHASE1/PHASE2

Clinical Investigation of the Nucleus® CI532 Cochlear Implant

NCT02392403

Hearing Loss

COMPLETED NA

Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia (Australia)

NCT06225336

Microtia

TERMINATED PHASE1

The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

NCT02941627

Hearing Loss, Sensorineural Hearing Loss, Cochlear Deafness

COMPLETED NA

Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

NCT03052920

Hearing Loss

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prominent Ears

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EARFOLD®

EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic

Group Type EXPERIMENTAL

EARFOLD®

Intervention Type DEVICE

EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EARFOLD®

EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects who have ear prominence and/or have significant asymmetry

Exclusion Criteria

* Subjects planning to use EARFOLD® in conjunction with other procedures (e.g. cartilage scoring, conchal reduction or concho-mastoid sutures) for correction of prominent ears are excluded
* Patients with impaired healing (e.g., current smokers, diabetic patients, patients with autoimmune disorders such as Ehlers-Danlos Syndrome or Scleroderma)
* Patients with an active infection, local or systemic
* Patients with known nickel or gold allergies.

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No