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

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

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

Conditions
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Prominent Ears

Intervention / Treatment
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* Device: EARFOLD®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EARFOLD®<br>EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic | Device: EARFOLD®<br>* EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pre-insertion in EAR-Q Ears Appearance Questionnaire score | 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) | Baseline to month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 12 months post-implantation | 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) | Baseline to Month 12 | 
| Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 24 months post-implantation | 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) | Baseline to Month 24 | 
| Percentage of patients that require re-operation at any moment | Percentage of patients that require re-operation at any moment during the investigational period | 24 months | 
| Percentage of patients with recurrence of ear prominence | Percentage of patients with recurrence of ear prominence at any moment during the investigational period | 24 months | 
| Change from baseline of Short Form-12 score at Month 3 for subjects over 18 years | The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being | Baseline to Month 3 | 
| Change from baseline of Short Form-12 score at Month 12 for subjects over 18 years | The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being | Baseline to Month 12 | 
| Change from baseline of Short Form-12 score at Month 24 for subjects over 18 years | The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being | Baseline to Month 24 | 
| Change from baseline of Short Form-10 score at Month 3 for subjects under 18 years old | The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being | Baseline to Month 3 | 
| Change from baseline of Short Form-10 score at Month 12 for subjects under 18 years old | The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being | Baseline to Month 12 | 
| Change from baseline of Short Form-10 score at Month 24 for subjects under 18 years old | The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being | Baseline to Month 24 | 
| Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 3 | Helix to scalp distance with untreated ears compared to EARFOLD in | Baseline to Month 3 | 
| Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 12 | Helix to scalp distance with untreated ears compared to EARFOLD in | Baseline to Month 12 | 
| Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 24 | Helix to scalp distance with untreated ears compared to EARFOLD in | Baseline to Month 24 | 
| Maintenance of maximum helix to scalp distance at 12 months compared to 3 months visit post insertion of EARFOLD | Helix to scalp distance with EARFOLD inserted | Month 3 to Month 12 | 
| Maintenance of maximum helix to scalp distance at 24 months compared to 3 months visit post insertion of EARFOLD | Helix to scalp distance with EARFOLD inserted | Month 3 to Month 24 | 
| Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 3 | Helix to scalp distance with PREFOLD® in compared with EARFOLD in | Baseline to Month 3 | 
| Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 12 | Helix to scalp distance with PREFOLD® in compared with EARFOLD in | Baseline to Month 12 | 
| Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 24 | Helix to scalp distance with PREFOLD® in compared with EARFOLD in | Baseline to Month 24 | 
| Duration of EARFOLD® insertion procedure | From the first incision of the scalpel to the last application of the sterristrip over the wound, duration of surgery | Duration of surgery | 
| Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 3 | EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 3 | 
| Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 12 | EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 12 | 
| Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 24 | EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 24 | 
| Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 3 | EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 3 | 
| Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 12 | EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 12 | 
| Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 24 | EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 24 | 
| Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 3 | EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 3 | 
| Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 12 | EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 12 | 
| Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 24 | EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 24 | 
| Return to normal activities questionnaire after EARFOLD® surgery at Month 3 | Return to normal activities questionnaire is on a 11-point scale ranging from 10=strongly agree to 0=strongly disagree | Month 3 |