Status:
COMPLETED
Feasibility Evaluation of OtoSet
Lead Sponsor:
SafKan
Conditions:
Cerumen Impaction of Both Ears
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after ...
Detailed Description
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after ...
Eligibility Criteria
Inclusion
- Mild (1), Moderate (2), or Complete (3) occlusion of the ear canal based on the Degree of Occlusion Scale in one or both ears
- Informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Exclusion
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
- Subject has life threatening illness
- Subject has immune deficiency
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04743817
Start Date
March 31 2021
End Date
October 21 2021
Last Update
May 12 2022
Active Locations (2)
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1
Eclipse Clinical Research
Tucson, Arizona, United States, 85745
2
Rainier Clinical Research Center
Renton, Washington, United States, 98057