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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by OtoSonics Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
OtoSonics Inc.
ClinicalTrials.gov Identifier:
NCT01421199
First received: August 18, 2011
Last updated: August 19, 2011
Last verified: August 2011

August 18, 2011
August 19, 2011
September 2011
December 2011   (final data collection date for primary outcome measure)
detection of middle ear fluid [ Time Frame: day one ] [ Designated as safety issue: No ]
device will be used during myringotomy procedure to detect middle ear fluid
Same as current
Complete list of historical versions of study NCT01421199 on ClinicalTrials.gov Archive Site
fluid viscosity [ Time Frame: day one ] [ Designated as safety issue: No ]
fluid obtained during myringotomy will be tested for viscosity
Same as current
Not Provided
Not Provided
 
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
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
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
  • Otitis Media With Effusion
  • Middle Ear Effusion
Procedure: Myringotomy
tube placement for children with multiple ear infections
Other Name: ear tubes
Myringotomy
On arm
Intervention: Procedure: Myringotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
125
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
6 Months to 17 Years
No
Contact: Mark E Boseley, MD 253.968.1430
Contact: Shaun Nguyen, MD 843.792.1356
Not Provided
 
NCT01421199
OTO-Myr
No
OtoSonics Inc.
OtoSonics Inc.
Not Provided
Principal Investigator: Mark E Boseley, MD Madigan Army Medical Center
OtoSonics Inc.
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP