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Completed

NCT Number: NCT04743817

Feasibility Evaluation of OtoSet

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.

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Key information

Conditions

Cerumen Impaction of Both Ears

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eclipse Clinical Research, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OtoSet - Ear Cleaning System

Device

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

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

SafKan

Industry

Registry information

Official study title

Feasibility Evaluation of the OtoSet - Ear Cleaning System

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2021
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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