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

Otitis Media With Effusion Clinical Trial

Official title:
A Prospective, Multi Center, Non-randomized Clinical Trial to Evaluate the Ear Effusion Detection and Characterization System (EEDCS) to Detect and Characterize Middle Ear Fluid in Children

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01421199
Study type Interventional
Source OtoSonics Inc.
Contact Mark E Boseley, MD
Phone 253.968.1430
Status Not yet recruiting
Phase N/A
Start date September 2011
Completion date December 2011
View Details
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