Cerumen Impaction of Both EarsEMSNCT04653662
Earol Madrid Study
A study testing Earol in people with Cerumen Impaction of Both Ears, run by HL Healthcare Ltd at 5 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerumen Impaction of Both Ears
- What is being tested?
- Earol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 5 sitesSpain
- Study dates
- 3 Dec 2019to 26 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Clínica Universidad de Navarra
Madrid
Hospital QuironSalud Madrid
Madrid
Hospital Universitario de Getafe
Madrid
Hospital QuironSalud Marbella
Marbella
Hospital Quirónsalud Infanta Luisa
Seville
About this study
Official title: Multi-center, Open-label, Non-randomized, Single-arm Clinical Study to Assess the Safety and Performance of Earol® in Adult Patients With Ear Wax
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.
Read more
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
- Being tested
- Earol
- Keywords
- Ear Wax Removal, Ear Wax, Earol, Olive oil, Cerumen, Impaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarolDevice
Also called Ear Wax removal
Treated with Earol on both ears and subsequent removal after 6 days of application
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Treatment group arm. Open label. Only 1 arm study Receives: Device: Earol |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAEs and AEs reported
Adverse Events (AEs) and Serious Adverse Events (SAEs) post-treatment
Measured: Day 6
Secondary outcomes (5)
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 %
Measured: 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).
Measured: 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).
Measured: Day 0 and Day 6
SAEs and AEs reported
Adverse Events (AEs) and Serious Adverse Events (SAEs) post-treatment.
Measured: 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
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start3 Dec 2019
- Primary completion17 Jun 2021
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerumen Impaction of Both EarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- HL Healthcare Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AKRN Scientific Consulting, S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653662
- Sponsor's protocol ID
- CD1620-001
- Acronym
- EMS
- Status last verified
- Mar 2023
- First submitted
- 16 Nov 2020
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open-label, Non-randomized, Single-arm Clinical Study to Assess the Safety and Performance of Earol® in Adult Patients With Ear Wax
- ClinicalTrials.gov ID
- NCT04653662
- Acronym / sponsor ID
- EMS / CD1620-001
- Conditions
- Cerumen Impaction of Both Ears
- Keywords
- Ear Wax Removal, Ear Wax, Earol, Olive oil, Cerumen, Impaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- HL Healthcare LtdIndustry (pharma, biotech, devices)
- Collaborators
- AKRN Scientific Consulting, S.L.
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: EarolTreatment group arm. Open label. Only 1 arm study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EarolAlso: Ear Wax removalTreated with Earol on both ears and subsequent removal after 6 days of application | Device | Treatment group |
Primary outcome
SAEs and AEs reported
Time frame: Day 6
Adverse Events (AEs) and Serious Adverse Events (SAEs) post-treatment
5 secondary outcomes
Cerumen blockage assesment
Time frame: Day 0 and Day 6
Ear clinical symptoms
Time frame: Day 0 and Day 6
Patient clinical symptoms
Time frame: Day 0 and Day 6
SAEs and AEs reported
Time frame: Day 12
Patient clinical symptom and ease-of-use
Time frame: Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Earol in people with Cerumen Impaction of Both Ears, run by HL Healthcare Ltd at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAEs and AEs reported (time frame: Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.