Cerumen Impaction of Both Ears
Conditions
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 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.
Interventions
DEVICEOtoSet - Ear Cleaning System
Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System
Sponsors
SafKan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as Assessed by Occlusion Scale | Treatment Visit (Day 1) (pre- to post-procedure) | Improvement of 1.0 on the Degree of Occlusion Scale (4 point scale) pre- and post-procedure evaluation (score 0 = no occlusion; 3 = complete occlusion) |
| Safety as Assessed by Adverse Events | Treatment Visit (Day 1) through follow-up call (Day 2-4) | Incidence of adverse events with severity defined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (4 point scale) (1 = mild; 4 = life-threatening) |
Countries
United States
Outcome results
None listed