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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):
OtoSonics Inc.

Tracking Information
First Submitted Date  ICMJE August 18, 2011
First Posted Date  ICMJE August 22, 2011
Last Update Posted Date August 22, 2011
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2011)
detection of middle ear fluid [ Time Frame: day one ]
device will be used during myringotomy procedure to detect middle ear fluid
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2011)
fluid viscosity [ Time Frame: day one ]
fluid obtained during myringotomy will be tested for viscosity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Otitis Media With Effusion
  • Middle Ear Effusion
Intervention  ICMJE Procedure: Myringotomy
tube placement for children with multiple ear infections
Other Name: ear tubes
Study Arms  ICMJE Myringotomy
On arm
Intervention: Procedure: Myringotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 19, 2011)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01421199
Other Study ID Numbers  ICMJE OTO-Myr
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party OtoSonics Inc.
Study Sponsor  ICMJE OtoSonics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark E Boseley, MD Madigan Army Medical Center
PRS Account OtoSonics Inc.
Verification Date August 2011

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