Prominent Ears
Conditions
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.
Interventions
DEVICEEARFOLD®
EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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-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 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) |
| 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) |
| 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-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 |
| 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 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 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 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 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 |
| 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 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 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 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 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 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 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 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 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 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 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) |
| 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed