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

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ClinicalTrials.gov Identifier: NCT03194269
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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.

Condition or disease Intervention/treatment Phase
Prominent Ears Device: EARFOLD® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FOLD: Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears
Actual Study Start Date : August 17, 2017
Estimated Primary Completion Date : October 28, 2020
Estimated Study Completion Date : October 28, 2020

Arm Intervention/treatment
Experimental: EARFOLD®
EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic
Device: EARFOLD®
EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic




Primary Outcome Measures :
  1. Change from baseline pre-insertion in EAR-Q Ears Appearance Questionnaire score [ Time Frame: Baseline to month 3 ]
    EAR-Q Ears Appearance Questionnaire is on a 4 point scale (1=Not at all, 2=A little bit, 3=Quite a bit, 4=Very much)


Secondary Outcome Measures :
  1. Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 12 months post-implantation [ Time Frame: Baseline to Month 12 ]
    EAR-Q Ears Appearance Questionnaire is on a 4 point scale (1=Not at all, 2=A little bit, 3=Quite a bit, 4=Very much)

  2. Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 24 months post-implantation [ Time Frame: Baseline to Month 24 ]
    EAR-Q Ears Appearance Questionnaire is on a 4 point scale (1=Not at all, 2=A little bit, 3=Quite a bit, 4=Very much)

  3. Percentage of patients that require re-operation at any moment [ Time Frame: 24 months ]
    Percentage of patients that require re-operation at any moment during the investigational period

  4. Percentage of patients with recurrence of ear prominence [ Time Frame: 24 months ]
    Percentage of patients with recurrence of ear prominence at any moment during the investigational period

  5. Change from baseline of Short Form-12 score at Month 3 for subjects over 18 years [ Time Frame: Baseline to Month 3 ]
    The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being

  6. Change from baseline of Short Form-12 score at Month 12 for subjects over 18 years [ Time Frame: Baseline to Month 12 ]
    The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being

  7. Change from baseline of Short Form-12 score at Month 24 for subjects over 18 years [ Time Frame: Baseline to Month 24 ]
    The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being

  8. Change from baseline of Short Form-10 score at Month 3 for subjects under 18 years old [ Time Frame: Baseline to Month 3 ]
    The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being

  9. Change from baseline of Short Form-10 score at Month 12 for subjects under 18 years old [ Time Frame: Baseline to Month 12 ]
    The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being

  10. Change from baseline of Short Form-10 score at Month 24 for subjects under 18 years old [ Time Frame: Baseline to Month 24 ]
    The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being

  11. Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 3 [ Time Frame: Baseline to Month 3 ]
    Helix to scalp distance with untreated ears compared to EARFOLD in

  12. Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 12 [ Time Frame: Baseline to Month 12 ]
    Helix to scalp distance with untreated ears compared to EARFOLD in

  13. Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 24 [ Time Frame: Baseline to Month 24 ]
    Helix to scalp distance with untreated ears compared to EARFOLD in

  14. Maintenance of maximum helix to scalp distance at 12 months compared to 3 months visit post insertion of EARFOLD [ Time Frame: Month 3 to Month 12 ]
    Helix to scalp distance with EARFOLD inserted

  15. Maintenance of maximum helix to scalp distance at 24 months compared to 3 months visit post insertion of EARFOLD [ Time Frame: Month 3 to Month 24 ]
    Helix to scalp distance with EARFOLD inserted

  16. Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 3 [ Time Frame: Baseline to Month 3 ]
    Helix to scalp distance with PREFOLD® in compared with EARFOLD in

  17. Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 12 [ Time Frame: Baseline to Month 12 ]
    Helix to scalp distance with PREFOLD® in compared with EARFOLD in

  18. Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 24 [ Time Frame: Baseline to Month 24 ]
    Helix to scalp distance with PREFOLD® in compared with EARFOLD in

  19. Duration of EARFOLD® insertion procedure [ Time Frame: Duration of surgery ]
    From the first incision of the scalpel to the last application of the sterristrip over the wound, duration of surgery

  20. Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 3 [ Time Frame: Baseline to Month 3 ]
    EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)

  21. Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 12 [ Time Frame: Baseline to Month 12 ]
    EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)

  22. Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 24 [ Time Frame: Baseline to Month 24 ]
    EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)

  23. Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 3 [ Time Frame: Baseline to Month 3 ]
    EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)

  24. Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 12 [ Time Frame: Baseline to Month 12 ]
    EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)

  25. Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 24 [ Time Frame: Baseline to Month 24 ]
    EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)

  26. Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 3 [ Time Frame: Baseline to Month 3 ]
    EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)

  27. Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 12 [ Time Frame: Baseline to Month 12 ]
    EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)

  28. Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 24 [ Time Frame: Baseline to Month 24 ]
    EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)

  29. Return to normal activities questionnaire after EARFOLD® surgery at Month 3 [ Time Frame: Month 3 ]
    Return to normal activities questionnaire is on a 11-point scale ranging from 10=strongly agree to 0=strongly disagree



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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194269


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@allergan.com

Locations
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United Kingdom
Royal Derby Hospital Recruiting
Derby, Derbyshire, United Kingdom, DE22 3NE
The Private Health Practice Recruiting
Salisbury, Wiltshire, United Kingdom, SP1 3SL
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Michael Silberberg Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03194269     History of Changes
Other Study ID Numbers: CMO-EAME-FAS-0469
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No