Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children

OtoSonics Inc.125 enrolled

Overview

The study has three objectives: 1. To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy) 2. If fluid is present to characterize the fluid as thick or thin 3. Evaluate the safety of the device

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

125

Conditions

Otitis Media With Effusion Middle Ear Effusion

Interventions

MyringotomyPROCEDURE

tube placement for children with multiple ear infections

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 6 months to 17 years * scheduled to undergo myringotomy procedure Exclusion Criteria: * mastoiditis * tympanostomy tubes * chronic middle ear disease * otitis externa * perforations of the middle ear * use of antibiotic ear drops within 2 days of surgery * systemic antibiotic use

Outcomes

Primary Outcomes

detection of middle ear fluid

device will be used during myringotomy procedure to detect middle ear fluid

Time frame: day one

Secondary Outcomes

fluid viscosity

fluid obtained during myringotomy will be tested for viscosity

Time frame: day one

Central Contacts

Mark E Boseley, MD

CONTACT

253.968.1430

Shaun Nguyen, MD

CONTACT

843.792.1356

Data from ClinicalTrials.gov

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