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Feasibility Evaluation of OtoSet

NCT04743817 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-05-12

No results posted yet for this study

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.

Conditions

  • Cerumen Impaction of Both Ears

Interventions

DEVICE

OtoSet - Ear Cleaning System

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

Sponsors & Collaborators

  • SafKan

    lead INDUSTRY

Principal Investigators

  • Felice Anderson · Eclipse Clinical Research

  • Ronald Brazg, MD, FACE · Rainier Clinical Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2021-10-21
Completion
2021-10-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04743817 on ClinicalTrials.gov