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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421199
Recruitment Status : Unknown
Verified August 2011 by OtoSonics Inc..
Recruitment status was:  Not yet recruiting
First Posted : August 22, 2011
Last Update Posted : August 22, 2011
Information provided by (Responsible Party):
OtoSonics Inc.

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 characterize the fluid as thick or thin
  3. Evaluate the safety of the device

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Middle Ear Effusion Procedure: Myringotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
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
Study Start Date : September 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
On arm
Procedure: Myringotomy
tube placement for children with multiple ear infections
Other Name: ear tubes

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421199

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

Sponsors and Collaborators
OtoSonics Inc.
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Principal Investigator: Mark E Boseley, MD Madigan Army Medical Center
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Responsible Party: OtoSonics Inc. Identifier: NCT01421199    
Other Study ID Numbers: OTO-Myr
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: August 22, 2011
Last Verified: August 2011
Keywords provided by OtoSonics Inc.:
Otitis Media with Effusion
Middle Ear Effusion
Additional relevant MeSH terms:
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Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases