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

September 1, 2022 updated by: Allergan

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline pre-insertion in EAR-Q Ears Appearance Questionnaire score
Time Frame: Baseline to month 3
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 12 months post-implantation
Time Frame: Baseline to Month 12
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
Time Frame: Baseline to Month 24
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
Time Frame: 24 months
Percentage of patients that require re-operation at any moment during the investigational period
24 months
Percentage of patients with recurrence of ear prominence
Time Frame: 24 months
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
Time Frame: Baseline to Month 3
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
Time Frame: Baseline to Month 12
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
Time Frame: Baseline to Month 24
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
Time Frame: Baseline to Month 3
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
Time Frame: Baseline to Month 12
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
Time Frame: Baseline to Month 24
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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Month 3 to Month 12
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
Time Frame: Month 3 to Month 24
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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to Month 24
Helix to scalp distance with PREFOLD® in compared with EARFOLD in
Baseline to Month 24
Duration of EARFOLD® insertion procedure
Time Frame: Duration of surgery
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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 7, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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