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

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

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 Overview

• Status: Completed
• Conditions: Prominent Ears
• Intervention / Treatment: Device: EARFOLD®

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G1 1SS
    • La Belle Forme /ID# 233664
  • Liverpool, United Kingdom, L1 9DS
    • Sthetix /ID# 233668
  • Salisbury, United Kingdom, SP1 3SL
    • Medcentres Plus /ID# 233687
  • Wolvehampton, United Kingdom, WV6 0BW
    • AL Aesthetics /ID# 233672
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • University Hospital of Derby and Burton NHS Foundation Trust /ID# 233610
  • London, City Of
    • London, London, City Of, United Kingdom, NW3 2QG
      • The Royal Free London NHS Foundation Trust /ID# 233617

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EARFOLD®; EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic	Device: EARFOLD®; EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2017
• Primary Completion (Actual): September 7, 2021
• Study Completion (Actual): September 7, 2021

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CMO-EAME-FAS-0469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No