Clinical trial NCT03194269: Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears
Official title: FOLD: Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prominent Ears
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-06-21
Enrollment: 84
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline pre-insertion in EAR-Q Ears Appearance Questionnaire score
timeFrame: Baseline to month 3
Secondary outcomes:
measure: Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 12 months post-implantation
timeFrame: Baseline to Month 12
measure: Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 24 months post-implantation
timeFrame: Baseline to Month 24
measure: Percentage of patients that require re-operation at any moment
timeFrame: 24 months
measure: Percentage of patients with recurrence of ear prominence
timeFrame: 24 months
measure: Change from baseline of Short Form-12 score at Month 3 for subjects over 18 years
timeFrame: Baseline to Month 3
measure: Change from baseline of Short Form-12 score at Month 12 for subjects over 18 years
timeFrame: Baseline to Month 12
measure: Change from baseline of Short Form-12 score at Month 24 for subjects over 18 years
timeFrame: Baseline to Month 24
measure: Change from baseline of Short Form-10 score at Month 3 for subjects under 18 years old
timeFrame: Baseline to Month 3
measure: Change from baseline of Short Form-10 score at Month 12 for subjects under 18 years old
timeFrame: Baseline to Month 12
measure: Change from baseline of Short Form-10 score at Month 24 for subjects under 18 years old
timeFrame: Baseline to Month 24
measure: Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 3
timeFrame: Baseline to Month 3
measure: Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 12
timeFrame: Baseline to Month 12
measure: Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 24
timeFrame: Baseline to Month 24
measure: Maintenance of maximum helix to scalp distance at 12 months compared to 3 months visit post insertion of EARFOLD
timeFrame: Month 3 to Month 12
measure: Maintenance of maximum helix to scalp distance at 24 months compared to 3 months visit post insertion of EARFOLD
timeFrame: Month 3 to Month 24
measure: Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 3
timeFrame: Baseline to Month 3
measure: Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 12
timeFrame: Baseline to Month 12
measure: Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 24
timeFrame: Baseline to Month 24
measure: Duration of EARFOLD® insertion procedure
timeFrame: Duration of surgery
measure: Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 3
timeFrame: Baseline to Month 3
measure: Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 12
timeFrame: Baseline to Month 12
measure: Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 24
timeFrame: Baseline to Month 24
measure: Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 3
timeFrame: Baseline to Month 3
measure: Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 12
timeFrame: Baseline to Month 12
measure: Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 24
timeFrame: Baseline to Month 24
measure: Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 3
timeFrame: Baseline to Month 3
measure: Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 12
timeFrame: Baseline to Month 12
measure: Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 24
timeFrame: Baseline to Month 24
measure: Return to normal activities questionnaire after EARFOLD® surgery at Month 3
timeFrame: Month 3
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University Hospital of Derby and Burton NHS Foundation Trust /ID# 233610
state: Derbyshire
city: London
country: United Kingdom
facility: The Royal Free London NHS Foundation Trust /ID# 233617
state: London, City Of
city: Glasgow
country: United Kingdom
facility: La Belle Forme /ID# 233664
city: Liverpool
country: United Kingdom
facility: Sthetix /ID# 233668
city: Salisbury
country: United Kingdom
facility: Medcentres Plus /ID# 233687
city: Wolvehampton
country: United Kingdom
facility: AL Aesthetics /ID# 233672
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: