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

This study is not yet open for participant recruitment.
Verified August 2011 by OtoSonics Inc.
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
History of Changes
  Purpose

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 Blind (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:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by OtoSonics Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • fluid viscosity [ Time Frame: day one ] [ Designated as safety issue: No ]
    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
Myringotomy
On arm
 Procedure: Myringotomy
tube placement for children with multiple ear infections
Other Name: ear tubes

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: OtoSonics Inc.
ClinicalTrials.gov Identifier: NCT01421199     History of Changes
Other Study ID Numbers: OTO-Myr
Study First Received: August 18, 2011
Last Updated: August 19, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 19, 2013