Status:
COMPLETED
Safety and Effectiveness of an Auricular Spray
Lead Sponsor:
YSLab
Conditions:
Excessive Ear Wax
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test the safety and efficacy of a medical device in subjects with cerumen in excess. The main questions it aims to answer are: * Does the medical device induce s...
Detailed Description
Ocean Bio Actif Hygiène de l'oreille is a medical device class IIa indicated for the prevention of the formation of earwax plugs and consequently the pathologies linked to the accumulation of earwax (...
Eligibility Criteria
Inclusion
- Gender: female and/or male.
- Age:
- 30 to 40% having age between 3 to 12 yo, 30 to 40% between 13 to 65 yo, 30 to 40% more than 65 yo.
- Subjects able to use the tested product.
- Subjects having history of cerumen occlusion more than once a year with or without symptoms (reduction of hearing function, obstruction feeling of the ear canal,..).
- Subjects having ear help system or regular users of systems such as anti-noise plugs or headsets (only for the 13yo subjects and more).
- Subjects having a clinical score of ear canal obstruction of 2 or 3 at D0.
Exclusion
- Subjects who had chirurgical act on the mastoïde.
- Subjects who had severe troubles of the internal ear (severe dizziness, desorientation, nausea).
- Subjects using regularly a ear spray for washing his/her ears.
- Subjects having a score of ear canal obstruction at 4 at D0.
- Pregnant or nursing woman or planning a pregnancy during the study;
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
- Subject in a social or sanitary establishment;
- Subject suspected to be non-compliant according to the investigator's judgment;
- Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
- Subject suffering from a severe or progressive disease.
Key Trial Info
Start Date :
February 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2024
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06085443
Start Date
February 6 2024
End Date
July 24 2024
Last Update
July 10 2025
Active Locations (1)
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1
Eurofins Dermscan Poland
Gdansk, Ul. Matuszewskiego 12, Poland, 80-288