Trials / Completed
CompletedNCT04743817
Feasibility Evaluation of OtoSet
Feasibility Evaluation of the OtoSet - Ear Cleaning System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- SafKan · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 by an evaluator.
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 by an evaluator. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Total duration of subject participation will be 1 day with a follow up call within 2-4 days after the procedure. Total duration of the study is expected to be 3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OtoSet - Ear Cleaning System | Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System |
Timeline
- Start date
- 2021-03-31
- Primary completion
- 2021-10-21
- Completion
- 2021-10-21
- First posted
- 2021-02-08
- Last updated
- 2022-05-12
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04743817. Inclusion in this directory is not an endorsement.