Earol Madrid Study

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    108
  • sponsor
    HL Healthcare Ltd
Updated on 15 March 2021

Summary

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).

Details
Condition Cerumen Impaction of Both Ears
Treatment Earol
Clinical Study IdentifierNCT04653662
SponsorHL Healthcare Ltd
Last Modified on15 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Cerumen Impaction of Both Ears??
Subject must be willing to provide written informed consent prior to any clinical investigation related procedure
Male or female patients over 18-year-old
Presence of ear wax in both ear canals with a minimum of > 50% ear wax blockage in at least one ear (level 4) and > 25% blockage in the contralateral ear (level 3) as assessed using the TMVSS
Subject must be willing and able to perform all the visits, follow the PI instructions and complete the follow-up of the study

Exclusion Criteria

Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study
Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
Presence of other anatomic or comorbid conditions (e.g. ear eczema or seborrhea), or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness
Presence or history of a tympanic membrane perforation or tympanostomy tubes at any time during the previous 6 months
Presence or history of a known or suspected ear infection (i.e. otitis externa or otitis interna) in the previous 2 months
Presence of a known or suspected chronic suppurative otitis media
Presence or history of a known or suspected keratosis obturans
Presence of known or suspected mastoiditis
Use of any ototopical drug or OTC product or ear wax-removal product (except for water or physiologic saline) during the preceding 3 days
Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions
Temporal bone neoplasm
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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