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

Not Applicable

• Conditions: Otitis Media With Effusion; Middle Ear Effusion
• Interventions: Procedure: Myringotomy

• Registration Number: NCT01421199
• Lead Sponsor: OtoSonics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-08-19
• Last Update Submitted: 2011-08-19
• Study First Posted: 2011-08-22
• Last Update Posted: 2011-08-22
• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myringotomy	Myringotomy	On arm

Primary Outcome Measures

Name	Time	Method
detection of middle ear fluid	day one	device will be used during myringotomy procedure to detect middle ear fluid

Secondary Outcome Measures

Name	Time	Method
fluid viscosity	day one	fluid obtained during myringotomy will be tested for viscosity