Feasibility Evaluation of OtoSet
Completed · Not applicable
Conditions studied: Cerumen Impaction of Both Ears
In brief
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 by an evaluator.
Key facts
- Study ID
- NCT04743817
- Run by
- SafKan
- People needed
- 110
- Starts
- 2021-03-31
- Expected to finish
- 2021-10-21
- Last updated by the study team
- 2022-05-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Eclipse Clinical Research — Tucson, Arizona, United States
- Rainier Clinical Research Center — Renton, Washington, United States
Full record on ClinicalTrials.gov
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