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

Allergan

Status and phase: Completed; Phase 4

Conditions: Prominent Ears

Treatments: Device: EARFOLD®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03194269

CMO-EAME-FAS-0469

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

EARFOLD®

Experimental group

Description:

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

Treatment:

Device: EARFOLD®