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

Prominent Ears Clinical Trial

— FOLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194269
• Other study ID #: CMO-EAME-FAS-0469
• Status: Completed
• Phase: Phase 4
• Start date: August 17, 2017
• Est. completion date: September 7, 2021

Study information

• Verified date: September 2022
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 7, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prominent Ears

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University Hospital of Derby and Burton NHS Foundation Trust /ID# 233610	Derby	Derbyshire
United Kingdom	La Belle Forme /ID# 233664	Glasgow
United Kingdom	Sthetix /ID# 233668	Liverpool
United Kingdom	The Royal Free London NHS Foundation Trust /ID# 233617	London	London, City Of
United Kingdom	Medcentres Plus /ID# 233687	Salisbury
United Kingdom	AL Aesthetics /ID# 233672	Wolvehampton

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis