[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"earwax-plug\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:earwax-plug":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100657048","performance-safety-and-participant-satisfaction-regarding-a-cerumen-medical-devices-used-for-the-removal-of-earwax-100657048",false,"NCT07834593","Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.","Post-Market Clinical Follow-Up to Assess the Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.","EAR","Inclusion Criteria:\n\n1. Adults (including pregnant and breastfeeding women) or children aged 3 years and older, in accordance with the IFU;\n2. 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.\n3. 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.\n4. Subject having daily access to internet to complete the online questionnaires.\n5. Subject able to understand verbal and written local language and in capacity to fill-in questionnaire by himself (or the parent for child).\n6. Subject who has been informed and has signed the informed consent form (or the parent for the child).\n7. Subject enrolled in a social security program (Art. L1121-8-1 of the CSP).\n\nExclusion Criteria:\n\n1. Contraindications specified in each device's instructions for use:\n\n   * In case of history of a damaged or perforated eardrum1,\n   * In case of otitis,\n   * subject with tympanostomy tubes (also called grommets) at the time of inclusion,\n   * In case of damaged skin of the ear canal.\n2. Known hypersensitivity or allergy to any of the investigational device's components.\n3. 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.\n4. Severe inner ear disorders or non-infectious ear conditions that may compromise participant safety, at the investigator's discretion.\n5. 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.\n6. For the ear assessed in the study: Use of A-CERUMEN® device (whatever the form) within 5 days prior to inclusion.\n7. Participation in another clinical trial or currently in the exclusion period of another clinical trial.\n8. Previous participation in this study.\n9. 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.\n10. 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\u002F745 on medical devices and Articles L.1121-5, L.1121-6, L.1121-8 of the Public Health Code (France):\n\n    * Parturient women,\n    * Subject deprived of liberty, hospitalized without consent, or admitted to a health or social care facility for purposes other than research,\n    * Adults under protective supervision (guardianship, curatorship).","ALL","3 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","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\u002Fbreastfeeding women.",[27,28,29],"Cerumen Impaction","Earwax Impaction","Earwax Plug",[31,32,33],"earwax","earwax plug","cerumen","NOT_YET_RECRUITING","2026-09-22",{"date":37,"type":38},"2026-09-25","ACTUAL",{"date":40,"type":21},"2026-10-15",{"date":42,"type":21},"2027-05-22",{"name":44,"class":45},"Laboratoires Gilbert","INDUSTRY",3]