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Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax. (EAR)

22 września 2026 zaktualizowane przez: Laboratoires Gilbert

Post-Market Clinical Follow-Up to Assess the Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.

The ear canal - or external auditory meatus - is lined with skin that contains ceruminous glands. Cerumen - or earwax - is a combination of epithelial cells, dust, foreign bodies, as well as the secretions of the sebaceous glands and apocrine glands. Cerumen is part of the external ear defense mechanisms against foreign bodies and infectious agents, lubricating and cleaning the ear canal. Cerumen production is a normal and protective process for the ear canal. Cerumen is naturally removed through the renewal of the skin in the external auditory meatus, and through the chewing movements of the jaw. Nonetheless, earwax plug - defined as an accumulation of cerumen - is a frequent occurrence across all age groups, with notably higher rates in vulnerable populations. Causes of earwax plug comprise attempts to remove wax, as well as ear canal deformity. It also has been suggested that ear cleaning with cotton buds, particularly when the external ear canal is wet, might be one of the important causes of cerumen impaction. Earwax plug leads to hearing loss that is easily treatable but can have significant cognitive and social consequences. They can also delay the diagnosis of certain ear conditions, such as ear infections, which can lead to medical complications and have economic implications. Effective treatment options for earwax plug include cerumenolytic agents (water-based agents, oil-based agents, surfactant-based agents), irrigation with or without cerumenolytic pre-treatment, and manual removal. Inappropriate treatment options include cotton-tipped swabs, ear candling, olive oil drops or sprays, and non-chewing diets. A-CERUMEN® devices correspond to cerumenolytic agents' products composed of surfactant-based agents. Although all the available data points towards a good performance and safety profile of the devices under evaluation, the clinical data surrounding the devices under evaluation is based on only one or two studies and there is currently no data available on A-CERUMEN® devices for the pediatric patient population, or on pregnant and breastfeeding women. To address this gap, LABORATOIRES GILBERT plans in the Clinical Evaluation Report (CER) a confirmatory clinical trial to collect further data in the adult population and data in the pediatric population, pregnant and breastfeeding women for the devices under evaluation. The Instructions for Use (IFU) should be updated in accordance with the findings of this study. In this context, LABORATOIRES GILBERT promotes a Post-Market Clinical Follow-Up (PMCF) study to assess independently performance, safety and patient satisfaction of A-CERUMEN® Spray and A-CERUMEN® Unidose devices. This PMCF study must include pediatric population and pregnant/breastfeeding women.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Francja
      • Amiens, Francja, 80054
        • CHU Amiens Picardie
        • Kontakt:
        • Główny śledczy:
          • Sandrine Soriot-Thomas, Dr
      • Brest, Francja, 29609
        • CHU de Brest - Hôpital Morvan
        • Kontakt:
        • Główny śledczy:
          • Rémi Marianowski, Pr
        • Pod-śledczy:
          • Jean-Christophe Leclere, Dr
      • Clermont-Ferrand, Francja, 63000
        • Hôpital Gabriel-Montpied
        • Kontakt:
        • Pod-śledczy:
          • Elise Sortais, Dr
        • Pod-śledczy:
          • Christian Jean Dualé, Dr
        • Główny śledczy:
          • Gisèle Pickering, Pr

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

3 lata i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. Adults (including pregnant and breastfeeding women) or children aged 3 years and older, in accordance with the IFU;
  2. Presence of earwax excess or an earwax plug in the external ear canal (only one ear included even if both are affected), confirmed by a score ≥2 according to the obstruction scale and without damage to the eardrum.
  3. Subject willing and able to comply with the study requirements throughout the study period (and the parent for the child), including returning for a follow-up visit at the study site between Day 5 and Day 7.
  4. Subject having daily access to internet to complete the online questionnaires.
  5. Subject able to understand verbal and written local language and in capacity to fill-in questionnaire by himself (or the parent for child).
  6. Subject who has been informed and has signed the informed consent form (or the parent for the child).
  7. Subject enrolled in a social security program (Art. L1121-8-1 of the CSP).

Exclusion Criteria:

  1. Contraindications specified in each device's instructions for use:

    • In case of history of a damaged or perforated eardrum1,
    • In case of otitis,
    • subject with tympanostomy tubes (also called grommets) at the time of inclusion,
    • In case of damaged skin of the ear canal.

  2. Known hypersensitivity or allergy to any of the investigational device's components.

  3. History of ear infection (suppurative otitis media, otitis interna, mastoiditis) within the 2 months prior to enrollment, or an otitis externa within the 2 weeks prior to enrollment.

  4. Severe inner ear disorders or non-infectious ear conditions that may compromise participant safety, at the investigator's discretion.

  5. For the ear assessed in the study: Use within 5 days prior to inclusion of an ear solution containing solvents that act on earwax and may have a prolonged effect.

  6. For the ear assessed in the study: Use of A-CERUMEN® device (whatever the form) within 5 days prior to inclusion.

  7. Participation in another clinical trial or currently in the exclusion period of another clinical trial.

  8. Previous participation in this study.

  9. Presence of a condition or abnormality (social or psychological disorders, anticipated poor compliance, or inability to communicate) or use of a medication by the subject that, in the investigator's opinion, would compromise the subject's safety or the quality of the data; or that would prevent compliance with follow-up requirements.

  10. Vulnerable subject, with the exception of minors over 3 years of age and pregnant and breastfeeding women listed in inclusion criterion No. 1, pursuant to Articles 64, 66 of Regulation (EU) 2017/745 on medical devices and Articles L.1121-5, L.1121-6, L.1121-8 of the Public Health Code (France):

    • Parturient women,
    • Subject deprived of liberty, hospitalized without consent, or admitted to a health or social care facility for purposes other than research,
    • Adults under protective supervision (guardianship, curatorship).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: A-CERUMEN® unidose

External ear cleaning solution in unidose container. Physiodose® will be used as rinsing solution after A-CERUMEN unidose application.
Urządzenie: Unidose cerumenolytic solution

A-CERUMEN® unidose with Physiodose® (as rinsing agent) for earwax excess removal during 4 days (8 applications)

Inne nazwy:
  • A-CERUMEN® unidose
Eksperymentalny: A-CERUMEN® spray

External ear cleaning solution, auricular spray. Physiodose® will be used as rinsing solution after A-CERUMEN spray application.
Urządzenie: Spray cerumenolytic solution

A-CERUMEN® spray with Physiodose® (as rinsing agent) for earwax excess removal during 4 days (8 applications)

Inne nazwy:
  • A-CERUMEN® spray

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Extent of earwax clearance using A-CERUMEN® Spray
Ramy czasowe: From enrollment to the end of treatment at 5-7 days

The primary outcome is the change in ear canal obstruction score measured before and after treatment, assessed by a blinded investigator using photographs of the ear canal. Ear canal obstruction is evaluated using a 5-point ear canal obstruction scale ranging from 0 (no obstruction, 0-2% of eardrum obscured) to 4 (severe obstruction, 76-100% of eardrum obscured). Higher scores indicate a worse outcome (greater obstruction).
From enrollment to the end of treatment at 5-7 days
Extent of earwax clearance using A-CERUMEN® Unidose
Ramy czasowe: From enrollment to the end of treatment at 5-7days

The primary outcome is the change in ear canal obstruction score measured before and after treatment, assessed by a blinded investigator using photographs of the ear canal. Ear canal obstruction is evaluated using a 5-point ear canal obstruction scale ranging from 0 (no obstruction, 0-2% of eardrum obscured) to 4 (severe obstruction, 76-100% of eardrum obscured). Higher scores indicate a worse outcome (greater obstruction).
From enrollment to the end of treatment at 5-7days

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of participants with complete earwax clearance using A-CERUMEN® Spray
Ramy czasowe: From enrollment to the end of treatment at 5-7days

Percentage of participants (or ears) achieving complete clearance of earwax, defined as an ear canal obstruction score of 0 after treatment, assessed by a blinded investigator based on photographs of the ear canal.
From enrollment to the end of treatment at 5-7days
Percentage of participants with at least one grade reduction in obstruction score using A-CERUMEN® Spray
Ramy czasowe: From enrollment to the end of treatment at 5-7 days

Percentage of participants (or ears) with a reduction of at least one grade in the ear canal obstruction score, assessed by a blinded investigator based on photographs of the ear canal.
From enrollment to the end of treatment at 5-7 days
Percentage of participants with complete earwax clearance using A-CERUMEN® Unidose
Ramy czasowe: From enrollment to the end of treatment at 5-7days

Percentage of participants (or ears) achieving complete clearance of earwax, defined as an ear canal obstruction score of 0 after treatment, assessed by a blinded investigator based on photographs of the ear canal.
From enrollment to the end of treatment at 5-7days
Percentage of participants with at least one grade reduction in obstruction score using A-CERUMEN® Unidose
Ramy czasowe: From enrollment to the end of treatment at 5-7 days

Percentage of participants (or ears) with a reduction of at least one grade in the ear canal obstruction score, assessed by a blinded investigator based on photographs of the ear canal.
From enrollment to the end of treatment at 5-7 days
Number of adverse device events using A-CERUMEN® Spray
Ramy czasowe: From enrollment to the end of treatment at 5-7days

Total number of adverse device events (ADEs) reported during the study period.
From enrollment to the end of treatment at 5-7days
Number of device deficiencies using A-CERUMEN® Spray
Ramy czasowe: From enrollment to the end of treatment at 5-7 days

Total number of device deficiencies (DDs) reported during the study period.
From enrollment to the end of treatment at 5-7 days
Percentage of participants with at least one adverse device event using A-CERUMEN® Spray
Ramy czasowe: From enrollment to the end of treatment at 5-7 days

Percentage of participants who experienced at least one adverse device event (ADE) during the study period.
From enrollment to the end of treatment at 5-7 days
Number of adverse device events using A-CERUMEN® Unidose
Ramy czasowe: From enrollment to the end of treatment at 5-7days

Total number of adverse device events (ADEs) reported during the study period.
From enrollment to the end of treatment at 5-7days
Number of device deficiencies using A-CERUMEN® Unidose
Ramy czasowe: From enrollment to the end of treatment at 5-7 days

Total number of device deficiencies (DDs) reported during the study period.
From enrollment to the end of treatment at 5-7 days
Percentage of participants with at least one adverse device event using A-CERUMEN® Unidose
Ramy czasowe: From enrollment to the end of treatment at 5-7 days

Percentage of participants who experienced at least one adverse device event (ADE) during the study period.
From enrollment to the end of treatment at 5-7 days
Daily change in earwax-related symptom intensity using A-CERUMEN® Spray
Ramy czasowe: Daily from enrollment to the end of treatment at 5-7days

Daily change in the intensity of earwax-related symptoms (irritation, clogged sensation, ringing/tinnitus, hearing loss, itching, pain, tingling, swelling) in participants who were symptomatic at inclusion. Evaluated using an 11-point numeric rating scale ranging from 0 (absence of symptom) to 10 (very intense symptom). Higher scores indicate a worse outcome (greater symptom intensity).
Daily from enrollment to the end of treatment at 5-7days
Percentage of participants with earwax symptom relief after using A-CERUMEN® Spray
Ramy czasowe: At the end of treatment (5-7 days)

Percentage of participants reporting relief of earwax-related symptoms at the end of treatment.
At the end of treatment (5-7 days)
Percentage of participants requiring further intervention for earwax removal after using A-CERUMEN® Spray
Ramy czasowe: At the end of treatment (5-7 days)

Percentage of participants requiring an additional medical or mechanical intervention to remove earwax after treatment with A-CERUMEN®.
At the end of treatment (5-7 days)
Daily change in earwax-related symptom intensity using A-CERUMEN® Unidose
Ramy czasowe: Daily from enrollment to the end of treatment at 5-7 days

Daily change in the intensity of earwax-related symptoms (irritation, clogged sensation, ringing/tinnitus, hearing loss, itching, pain, tingling, swelling) in participants who were symptomatic at inclusion. Evaluated using an 11-point numeric rating scale ranging from 0 (absence of symptom) to 10 (very intense symptom). Higher scores indicate a worse outcome (greater symptom intensity).
Daily from enrollment to the end of treatment at 5-7 days
Percentage of participants with earwax symptom relief after using A-CERUMEN® Unidose
Ramy czasowe: At the end of treatment (5-7 days)

Percentage of participants reporting relief of earwax-related symptoms at the end of treatment.
At the end of treatment (5-7 days)
Percentage of participants requiring further intervention for earwax removal after using A-CERUMEN® Unidose
Ramy czasowe: At the end of treatment (5-7 days)

Percentage of participants requiring an additional medical or mechanical intervention to remove earwax after treatment with A-CERUMEN®.
At the end of treatment (5-7 days)
Overall participant satisfaction with A-CERUMEN® Spray
Ramy czasowe: At the end of treatment or no later than Visit 2 (up to 7 days)

Overall participant (or parent) satisfaction regarding the treatment, assessed via the ePRO satisfaction questionnaire. Evaluated using an 11-point numeric rating scale ranging from 0 (not at all satisfied) to 10 (totally satisfied). Higher scores indicate a better outcome (greater satisfaction).
At the end of treatment or no later than Visit 2 (up to 7 days)
Ease of use and handling of A-CERUMEN® Spray and flushing method
Ramy czasowe: At the end of treatment or no later than Visit 2 (up to 7 days)

Participant (or parent) reported ease of handling, flushing effectiveness, and flushing practicality, assessed via the ePRO satisfaction questionnaire. Evaluated using 5-point Likert scales ranging from 1 (very difficult/poor) to 5 (very easy/good). Higher scores indicate a better outcome (greater ease/effectiveness/convenience).
At the end of treatment or no later than Visit 2 (up to 7 days)
Percentage of participants willing to reuse A-CERUMEN® Spray
Ramy czasowe: At the end of treatment or no later than Visit 2 (up to 7 days)

Percentage of participants (or parents) reporting they would reuse the product in case of earwax plugs, assessed via a binary question (yes/no) in the ePRO satisfaction questionnaire.
At the end of treatment or no later than Visit 2 (up to 7 days)
Overall participant satisfaction with A-CERUMEN® Unidose
Ramy czasowe: At the end of treatment or no later than Visit 2 (up to 7 days)

Overall participant (or parent) satisfaction regarding the treatment, assessed via the ePRO satisfaction questionnaire. Evaluated using an 11-point numeric rating scale ranging from 0 (not at all satisfied) to 10 (totally satisfied). Higher scores indicate a better outcome (greater satisfaction).
At the end of treatment or no later than Visit 2 (up to 7 days)
Ease of use and handling of A-CERUMEN® Unidose and flushing method
Ramy czasowe: At the end of treatment or no later than Visit 2 (up to 7 days)

Participant (or parent) reported ease of handling, flushing effectiveness, and flushing practicality, assessed via the ePRO satisfaction questionnaire. Evaluated using 5-point Likert scales ranging from 1 (very difficult/poor) to 5 (very easy/good). Higher scores indicate a better outcome (greater ease/effectiveness/convenience).
At the end of treatment or no later than Visit 2 (up to 7 days)
Percentage of participants willing to reuse A-CERUMEN® Unidose
Ramy czasowe: At the end of treatment or no later than Visit 2 (up to 7 days)

Percentage of participants (or parents) reporting they would reuse the product in case of earwax plugs, assessed via a binary question (yes/no) in the ePRO satisfaction questionnaire.
At the end of treatment or no later than Visit 2 (up to 7 days)
Adherence to A-CERUMEN® Spray treatment
Ramy czasowe: From enrollment to the end of treatment at 5-7 days

Number of A-CERUMEN® Spray applications administered during the treatment period (recommended usage: 2 applications per day for 4 days; target total: 8 applications).
From enrollment to the end of treatment at 5-7 days
Adherence to A-CERUMEN® Unidose treatment
Ramy czasowe: From the enrollment to the end of treatment at 5-7 days

Number of A-CERUMEN® Single-dose applications administered during the treatment period (recommended usage: 2 applications per day for 4 days; target total: 8 applications).
From the enrollment to the end of treatment at 5-7 days

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Laboratoires Gilbert

Współpracownicy

Slb Pharma

Śledczy

  • Główny śledczy: Marc Henocq, Dr

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 października 2026

Zakończenie podstawowe (Szacowany)

22 maja 2027

Ukończenie studiów (Szacowany)

22 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

10 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 września 2026

Pierwszy wysłany (Rzeczywisty)

22 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 2026-A00953-48

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

No individual participant data sharing is planned.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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