Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
NCT ID: NCT01421199
Last Updated: 2011-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
125 participants
INTERVENTIONAL
2011-09-30
2011-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Myringotomy
On arm
Myringotomy
tube placement for children with multiple ear infections
Interventions
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Myringotomy
tube placement for children with multiple ear infections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* scheduled to undergo myringotomy procedure
Exclusion Criteria
* 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
6 Months
17 Years
ALL
No
Sponsors
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OtoSonics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark E Boseley, MD
Role: PRINCIPAL_INVESTIGATOR
Madigan Army Medical Center
Central Contacts
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Mark E Boseley, MD
Role: CONTACT
Shaun Nguyen, MD
Role: CONTACT
Other Identifiers
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OTO-Myr
Identifier Type: -
Identifier Source: org_study_id
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