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

Active Locations (0)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 0 (0 locations)

No Results Found

We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.