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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by OtoSonics Inc..
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
OtoSonics Inc. Identifier:
First received: August 18, 2011
Last updated: August 19, 2011
Last verified: August 2011

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

Condition Intervention
Otitis Media With Effusion Middle Ear Effusion Procedure: Myringotomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by OtoSonics Inc.:

Primary Outcome Measures:
  • detection of middle ear fluid [ Time Frame: day one ]
    device will be used during myringotomy procedure to detect middle ear fluid

Secondary Outcome Measures:
  • fluid viscosity [ Time Frame: day one ]
    fluid obtained during myringotomy will be tested for viscosity

Estimated Enrollment: 125
Study Start Date: September 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
On arm
Procedure: Myringotomy
tube placement for children with multiple ear infections
Other Name: ear tubes


Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01421199

Contact: Mark E Boseley, MD 253.968.1430
Contact: Shaun Nguyen, MD 843.792.1356

Sponsors and Collaborators
OtoSonics Inc.
Principal Investigator: Mark E Boseley, MD Madigan Army Medical Center
  More Information

Responsible Party: OtoSonics Inc. Identifier: NCT01421199     History of Changes
Other Study ID Numbers: OTO-Myr
Study First Received: August 18, 2011
Last Updated: August 19, 2011

Keywords provided by OtoSonics Inc.:
Otitis Media with Effusion
Middle Ear Effusion

Additional relevant MeSH terms:
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases processed this record on September 20, 2017