Accumulation of ear wax in the external ear canal is a common pathology. The presence of ear wax not only interferes with the clinician's view of the tympanic membrane, but may also result in hearing loss and vertigo, and may predispose to ear infections. Removal of ear wax is facilitated using a variety of cerumenolytics, or ear wax solvents. The current study is designed to evaluate the safety and the cerumenolytic effects of the Earol product, when dosed into the auditory canal prior to the dewaxing and ear cleaning procedure. This study is designed to be conducted in the primary care setting as a prospective clinical trial. A detailed literature review has been conducted to provide a background summary of relevant information on the disease/pathology, other available treatment options and the pre-clinical testing and clinical research that has been conducted to date on the intended population or related populations and/or the device. The aim for conducting this clinical investigation is to perform a PMCF to evaluate the safety and performance of Earol. Although there are alternative methods for ear wax removal, Earol represents a simple method based on natural ingredients (olive oil) which aids the removal of ear wax as well as prevents appearance of clinical symptoms in the ear canal (E.g. reducing itching and irritation).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Treated with Earol on both ears and subsequent removal after 6 days of application
Clínica Universidad de Navarra
Madrid, Spain
Hospital QuironSalud Madrid
Madrid, Spain
Hospital Universitario de Getafe
Madrid, Spain
Hospital QuironSalud Marbella
Marbella, Spain
Hospital Quirónsalud Infanta Luisa
Seville, Spain
SAEs and AEs reported
Adverse Events (AEs) and Serious Adverse Events (SAEs) post-treatment
Time frame: Day 6
Cerumen blockage assesment
Visualization of the tympanic membrane where cerumen blockage will be assessed post-treatment through the literature and protocol described tool TMVSS (Tympanic Membrane Visualization Scoring System). This scale measures the level of obstruction of the ear canal by assessing the level of obstruction when trying to visualize the tympanic membrane with an otoscope. Level of obstruction 1 - \< 3 % Level of obstruction 2 - 3 - 25 % Level of obstruction 3 - 26 - 50 % Level of obstruction 4 - 51 - 75 % Level of obstruction 5 - 76 - 100 %
Time frame: Day 0 and Day 6
Ear clinical symptoms
Evaluate ear-specific clinical symptoms (e.g. dryness and itchiness) through a MD questionnaire. This scale has been specifically developed for this clinical trial. \- Clinical symptoms questionnaire (MD): Incidence of clinical symptoms and assessment scale of the intensity and frequency of the clinical symptoms (itchiness and dryness).
Time frame: Day 0 and Day 6
Patient clinical symptoms
Patient Questionnaire collecting clinical symptom prior and post-treatment This scale has been specifically developed for this clinical trial. \- Clinical symptoms questionnaire (patient): Incidence of clinical symptoms and assessment scale of the intensity and frequency of the clinical symptoms (itchiness and dryness).
Time frame: Day 0 and Day 6
SAEs and AEs reported
Adverse Events (AEs) and Serious Adverse Events (SAEs) post-treatment.
Time frame: Day 12
Patient clinical symptom and ease-of-use
Patient Questionnaire assessing the ease-of-use of the medical device (Earol). This scale has been specifically developed for this clinical trial. \- Ease of use of the device questionnaire: rating scale 0 - 10
Time frame: Day 6
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