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Feasibility Evaluation of OtoSet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04743817
Recruitment Status : Not yet recruiting
First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
SafKan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cerumen Impaction of Both Ears Device: OtoSet - Ear Cleaning System Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Evaluation of the OtoSet - Ear Cleaning System
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: OtoSet - Ear Cleaning Sytem Device: OtoSet - Ear Cleaning System
Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy as Assessed by Occlusion Scale [ Time Frame: 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)

  2. Safety as Assessed by Adverse Events [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743817


Locations
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United States, Arizona
Eclipse Clinical Research
Tucson, Arizona, United States, 85745
Contact: Study Coordinator    520-647-9926      
Sponsors and Collaborators
SafKan
Investigators
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Principal Investigator: Felice Anderson Eclipse Clinical Research
More Information
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Responsible Party: SafKan
ClinicalTrials.gov Identifier: NCT04743817    
Other Study ID Numbers: SK-0119
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No