Post-Market Clinical Follow-Up to Assess the Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Extent of earwax clearance using A-CERUMEN® Spray
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (including pregnant and breastfeeding women) or children aged 3 years and older, in accordance with the IFU;
- •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.
- •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
- •Subject having daily access to internet to complete the online questionnaires.
- •Subject able to understand verbal and written local language and in capacity to fill-in questionnaire by himself (or the parent for child).
- •Subject who has been informed and has signed the informed consent form (or the parent for the child).
- •Subject enrolled in a social security program (Art. L1121-8-1 of the CSP).
排除标准
- •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.
- •Known hypersensitivity or allergy to any of the investigational device's components.
- •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.
- •Severe inner ear disorders or non-infectious ear conditions that may compromise participant safety, at the investigator's discretion.
- •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.
- •For the ear assessed in the study: Use of A-CERUMEN® device (whatever the form) within 5 days prior to inclusion.
- •Participation in another clinical trial or currently in the exclusion period of another clinical trial.
- •Previous participation in this study.
- •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.
- •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).
研究组 & 干预措施
A-CERUMEN® unidose
External ear cleaning solution in unidose container. Physiodose® will be used as rinsing solution after A-CERUMEN unidose application.
干预措施: Unidose cerumenolytic solution (Device)
A-CERUMEN® spray
External ear cleaning solution, auricular spray. Physiodose® will be used as rinsing solution after A-CERUMEN spray application.
干预措施: Spray cerumenolytic solution (Device)
结局指标
主要结局
Extent of earwax clearance using A-CERUMEN® Spray
时间窗: 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).
Extent of earwax clearance using A-CERUMEN® Unidose
时间窗: 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).
次要结局
- Percentage of participants with complete earwax clearance using A-CERUMEN® Unidose(From enrollment to the end of treatment at 5-7days)
- Percentage of participants with complete earwax clearance using A-CERUMEN® Spray(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(From enrollment to the end of treatment at 5-7 days)
- Number of device deficiencies using A-CERUMEN® Unidose(From enrollment to the end of treatment at 5-7 days)
- Percentage of participants with at least one grade reduction in obstruction score using A-CERUMEN® Unidose(From enrollment to the end of treatment at 5-7 days)
- Number of adverse device events using A-CERUMEN® Spray(From enrollment to the end of treatment at 5-7days)
- Number of device deficiencies using A-CERUMEN® Spray(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(From enrollment to the end of treatment at 5-7 days)
- Number of adverse device events using A-CERUMEN® Unidose(From enrollment to the end of treatment at 5-7days)
- Percentage of participants with at least one adverse device event using A-CERUMEN® Unidose(From enrollment to the end of treatment at 5-7 days)
- Daily change in earwax-related symptom intensity using A-CERUMEN® Spray(Daily from enrollment to the end of treatment at 5-7days)
- Percentage of participants with earwax symptom relief after using A-CERUMEN® Spray(At the end of treatment (5-7 days))
- Percentage of participants requiring further intervention for earwax removal after using A-CERUMEN® Spray(At the end of treatment (5-7 days))
- Daily change in earwax-related symptom intensity using A-CERUMEN® Unidose(Daily from enrollment to the end of treatment at 5-7 days)
- Percentage of participants with earwax symptom relief after using A-CERUMEN® Unidose(At the end of treatment (5-7 days))
- Percentage of participants requiring further intervention for earwax removal after using A-CERUMEN® Unidose(At the end of treatment (5-7 days))
- Overall participant satisfaction with A-CERUMEN® Spray(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(At the end of treatment or no later than Visit 2 (up to 7 days))
- Percentage of participants willing to reuse A-CERUMEN® Spray(At the end of treatment or no later than Visit 2 (up to 7 days))
- Overall participant satisfaction with A-CERUMEN® Unidose(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(At the end of treatment or no later than Visit 2 (up to 7 days))
- Percentage of participants willing to reuse A-CERUMEN® Unidose(At the end of treatment or no later than Visit 2 (up to 7 days))
- Adherence to A-CERUMEN® Spray treatment(From enrollment to the end of treatment at 5-7 days)
- Adherence to A-CERUMEN® Unidose treatment(From the enrollment to the end of treatment at 5-7 days)