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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Otitis Media With Effusion Middle Ear Effusion Procedure: Myringotomy

Study Design

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
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01421199


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

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

Responsible Party: OtoSonics Inc.
ClinicalTrials.gov Identifier: NCT01421199     History of Changes
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:
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases