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
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
Status | Not yet recruiting |
Enrollment | 125 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 17 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
OtoSonics Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | detection of middle ear fluid | device will be used during myringotomy procedure to detect middle ear fluid | day one | No |
Secondary | fluid viscosity | fluid obtained during myringotomy will be tested for viscosity | day one | No |
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