Earol Madrid Study

NCT ID: NCT04653662

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2022-01-26

Brief 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).

Conditions

Cerumen Impaction of Both Ears

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Treatment group arm. Open label. Only 1 arm study

Group Type: EXPERIMENTAL

Earol

Intervention Type: DEVICE

Treated with Earol on both ears and subsequent removal after 6 days of application

Interventions

Earol

Treated with Earol on both ears and subsequent removal after 6 days of application

Intervention Type: DEVICE

Other Intervention Names

Ear Wax removal

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AKRN Scientific Consulting, S.L.

INDUSTRY

Sponsor Role: collaborator

HL Healthcare Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Spain

Other Identifiers

CD1620-001

Identifier Type: -

Identifier Source: org_study_id