Feasibility Evaluation of OtoSet

Cerumen Impaction of Both Ears Clinical Trial

Official title:

Feasibility Evaluation of the OtoSet - Ear Cleaning System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743817
• Other study ID #: SK-0119
• Status: Completed
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: October 21, 2021

Study information

• Verified date: May 2022
• Source: SafKan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 21, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerumen Impaction of Both Ears

Intervention

Device:
• OtoSet - Ear Cleaning System
Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System

Locations

Country	Name	City	State
United States	Rainier Clinical Research Center	Renton	Washington
United States	Eclipse Clinical Research	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
SafKan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as Assessed by Occlusion Scale	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)	Treatment Visit (Day 1) (pre- to post-procedure)
Primary	Safety as Assessed by Adverse Events	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)	Treatment Visit (Day 1) through follow-up call (Day 2-4)