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

Study Identifier
CMO-EAME-FAS-0469
CT.gov Identifier
NCT03194269
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Facial Aesthetics - Other
    • Study Drug
    N/A
    Phase
    Phase 4
    Sex
    Female & Male
    Age
    7+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

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

    Study Locations

    Location
    Status
    Location
    University Hospital of Derby and Burton NHS Foundation Trust /ID# 233610
    Derby, Derbyshire, United Kingdom, DE22 3NE
    Status
    Not applicable
    Location
    The Royal Free London NHS Foundation Trust /ID# 233617
    London, London, City Of, United Kingdom, NW3 2QG
    Status
    Not applicable
    Location
    La Belle Forme /ID# 233664
    Glasgow, United Kingdom, G1 1SS
    Status
    Not applicable
    Location
    Sthetix /ID# 233668
    Liverpool, United Kingdom, L1 9DS
    Status
    Not applicable
    Location
    Medcentres Plus /ID# 233687
    Salisbury, United Kingdom, SP1 3SL
    Status
    Not applicable
    Location
    AL Aesthetics /ID# 233672
    Wolvehampton, United Kingdom, WV6 0BW
    Status
    Not applicable