Status:
UNKNOWN
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
Lead Sponsor:
OtoSonics Inc.
Conditions:
Otitis Media With Effusion
Middle Ear Effusion
Eligibility:
All Genders
6-17 years
Phase:
NA
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 charac...
Eligibility Criteria
Inclusion
- 6 months to 17 years
- scheduled to undergo myringotomy procedure
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01421199
Start Date
September 1 2011
End Date
December 1 2011
Last Update
August 22 2011
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