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Completed

NCT Number: NCT03194269

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

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

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Key information

Conditions

Prominent Ears

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Derby and Burton NHS Foundation Trust /ID# 233610, Derby, Derbyshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EARFOLD®

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Acronym: FOLD

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2017
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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