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

Phase 4CompletedNCT03194269

Allergan84 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prominent Ears

Interventions

EARFOLD®DEVICE

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

Eligibility

Sex: ALLMin age: 7 Years

Medical Language ↔ Plain English

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.

Locations (6)

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

Sthetix /ID# 233668

Liverpool, United Kingdom

Outcomes

Primary Outcomes

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)

Time frame: Baseline to month 3

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline to Month 3

Change from baseline of Short Form-12 score at Month 12 for subjects over 18 years

Data from ClinicalTrials.gov

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Medcentres Plus /ID# 233687

Salisbury, United Kingdom

AL Aesthetics /ID# 233672

Wolvehampton, United Kingdom

The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: Month 3