Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears
- Conditions
- Prominent Ears
- Interventions
- Device: EARFOLD®
- Registration Number
- NCT03194269
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Subjects who have ear prominence and/or have significant asymmetry
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EARFOLD® EARFOLD® EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic
- Primary Outcome Measures
Name Time Method Change from baseline pre-insertion in EAR-Q Ears Appearance Questionnaire score 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
Name Time Method Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 24 months post-implantation 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)
Change from baseline of Short Form-10 score at Month 24 for subjects under 18 years old 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
Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 12 Baseline to Month 12 Helix to scalp distance with PREFOLD® in compared with EARFOLD in
Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 3 Baseline to Month 3 EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)
Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 12 months post-implantation 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)
Percentage of patients that require re-operation at any moment 24 months Percentage of patients that require re-operation at any moment during the investigational period
Change from baseline of Short Form-12 score at Month 24 for subjects over 18 years 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
Change from baseline of Short Form-12 score at Month 12 for subjects over 18 years 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
Change from baseline of Short Form-10 score at Month 3 for subjects under 18 years old 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
Change from baseline of Short Form-10 score at Month 12 for subjects under 18 years old 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
Percentage of patients with recurrence of ear prominence 24 months Percentage of patients with recurrence of ear prominence at any moment during the investigational period
Change from baseline of Short Form-12 score at Month 3 for subjects over 18 years 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
Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 12 Baseline to Month 12 Helix to scalp distance with untreated ears compared to EARFOLD in
Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 3 Baseline to Month 3 EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)
Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 3 Baseline to Month 3 Helix to scalp distance with untreated ears compared to EARFOLD in
Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 24 Baseline to Month 24 Helix to scalp distance with untreated ears compared to EARFOLD in
Maintenance of maximum helix to scalp distance at 12 months compared to 3 months visit post insertion of EARFOLD Month 3 to Month 12 Helix to scalp distance with EARFOLD inserted
Maintenance of maximum helix to scalp distance at 24 months compared to 3 months visit post insertion of EARFOLD Month 3 to Month 24 Helix to scalp distance with EARFOLD inserted
Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 3 Baseline to Month 3 Helix to scalp distance with PREFOLD® in compared with EARFOLD in
Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 24 Baseline to Month 24 Helix to scalp distance with PREFOLD® in compared with EARFOLD in
Duration of EARFOLD® insertion procedure Duration of surgery From the first incision of the scalpel to the last application of the sterristrip over the wound, duration of surgery
Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 3 Baseline to Month 3 EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)
Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 12 Baseline to Month 12 EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)
Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 24 Baseline to Month 24 EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)
Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 12 Baseline to Month 12 EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)
Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 24 Baseline to Month 24 EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)
Return to normal activities questionnaire after EARFOLD® surgery at Month 3 Month 3 Return to normal activities questionnaire is on a 11-point scale ranging from 10=strongly agree to 0=strongly disagree
Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 24 Baseline to Month 24 EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)
Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 12 Baseline to Month 12 EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)
Trial Locations
- Locations (6)
Sthetix /ID# 233668
🇬🇧Liverpool, United Kingdom
Medcentres Plus /ID# 233687
🇬🇧Salisbury, United Kingdom
University Hospital of Derby and Burton NHS Foundation Trust /ID# 233610
🇬🇧Derby, Derbyshire, United Kingdom
The Royal Free London NHS Foundation Trust /ID# 233617
🇬🇧London, London, City Of, United Kingdom
La Belle Forme /ID# 233664
🇬🇧Glasgow, United Kingdom
AL Aesthetics /ID# 233672
🇬🇧Wolvehampton, United Kingdom