FOLD:Study Of EARFOLD® For The Treatment Of Prominent Ears
Research type
Research Study
Full title
FOLD: Long Term Prospective Uncontrolled Study Of EARFOLD® For The Treatment Of Prominent Ears
IRAS ID
223680
Contact name
Norbert Kang
Contact email
Sponsor organisation
Allergan Pharmaceuticals International Limited
Duration of Study in the UK
3 years, 3 months, 7 days
Research summary
Summary of Research
This is a post-marketing study of the long-term safety and performance of EARFOLD® Prominent Ear Correction System in experienced UK EARFOLD® sites.
EARFOLD® is a Medical Device and does not include any drugs or toxic substances that enter the blood circulation.
Post-marketing means that the EARFOLD® Prominent Ear Correction System already has a CE mark and is authorised for use in the UK. The performance of EARFOLD® Prominent Ear Correction System will be assessed by the use of age-appropriate validated questionnaires and one non-validated questionnaire.
Participants over 7 years-old with prominent ears or significant differences when comparing left and right ears, treated with EARFOLD® as per the current EARFOLD® Instructions for Use, will be invited to participate in the clinical investigation.
It is estimated that approximately 100 participants will be included.
The study will have 5 visits. In the first visit, the doctor will discuss the treatment options with the participant. If EARFOLD® is an option, the doctor will discuss this study and provide an age appropriate participant information sheet to take home.
When the participant returns for EARFOLD® insertion, if the participant wishes to join the study, informed consent is taken and the surgical procedure carried out. The observational period for each participant will be for 24 months, or until removal (whichever is sooner), or participant withdrawal from the study for other reasons. The remaining visits will be scheduled during a 24 month prospective follow-up: Follow-Up 3 months post insertion (third visit), 12 month post insertion (fourth visit) and 24 month post insertion (fifth visit). If the participant is unable to return in person to attend the follow up visits a home visit from an appropriately qualified and trained nurse may be arranged.Summary of Results
Study Title:
FOLD: Long Term Prospective Uncontrolled Study Of EARFOLD® For The Treatment Of Prominent Ears We would like to thank all the study participants for their involvement in the study.
Who carried out the research?
This study was conducted at a total of six centres within the United Kingdom. The study was sponsored (funded) by Allergan Pharmaceuticals International Limited.
Where and when the study took place
This study was conducted within the United Kingdom in Derby, Glasgow, London, Liverpool, Salisbury and Wolverhampton. The study lasted for 4 years between Jul 2017 to Oct 2021.
A total of 85 participants aged between 8 and 70 were enrolled and treated and 44 participants completed the study. 41 participants discontinued the study, 30 of these did not return for the scheduled follow up visits. 5 participants withdrew their consent to continue participating, 5 participants discontinued for “other” reasons, and one participant discontinued due to failure to follow the Protocol instructions.
Why was the research needed?
The purpose of this study was to better understand how well the EARFOLD® device works for correcting prominent ears and what adverse reactions the EARFOLD® may cause during 2 years observation time.
What treatments or interventions did the participants take/receive?
Participants had chosen to have the EARFOLD® device inserted to help correct their prominent ear(s).
The study was intended to capture information about current practices in the management of prominent ears with the EARFOLD® without making any specific change to the treatment(s) selected by UK doctors as a standard of care.
What medical problems (adverse reactions) did the participants have?
Overall, 37 participants reported at least one adverse event (AE). 32 participants reported an AE related to the device.
Most of the reported AEs were mild. Minimal moderate AEs and no severe AEs were reported during the study. Most of the reported AEs had a causal relationship to the study device (were caused by the study device).
What were the results of the study?
The main measurement of effectiveness was the change from baseline in the Ears Appearance module of the EAR-Q questionnaires converted to a 100-point scale. Mean EAR-Q Ears Appearance scores from baseline to Month 3 increased by 41.9 points indicating an increase in participant satisfaction with ear appearance following the study treatment.
Mean EAR-Q Ears Appearance scores from baseline to Month 12 increased by 43.2 points and from baseline to Month 24 by 42.3 points indicating an increase in participant satisfaction with ear appearance following the study treatment continuing through 24 months post treatment.
At Visit 3 (Month 3), the Return to Normal Activities Questionnaire showed a mean of 7.7 for the question “I was able to return to my normal routine almost immediately after my EARFOLD surgery” and a mean of 6.9 for the question “My EARFOLD surgery did not bother me.” The mean for both questions indicate that participants were able to return to their normal routine almost immediately after surgery and that the surgery did not bother them.
Overall, recurrence of ear prominence was reported in over 70% of patients, assessed beginning at Month 3 and continuing through Month 24.
Overall, four patients (7.3%) reported four total reoperations. All four reoperations were reported in patients 16 years of age or older.How has this study helped patients and researchers?
The study provided information from participants observed over 24 months. Outside of the study, since patients are satisfied after the insertion of EARFOLD® device, they typically do not return to the doctor and follow up data cannot be collected.REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/0658
Date of REC Opinion
22 Jun 2017
REC opinion
Further Information Favourable Opinion