Back to resultsDevice Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
Primary Purpose
Otitis Media With Effusion, Middle Ear Effusion
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Myringotomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Otitis Media With Effusion focused on measuring Otitis Media with Effusion, Middle Ear Effusion
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Myringotomy
Arm Description
On arm
Outcomes
Primary Outcome Measures
detection of middle ear fluid
device will be used during myringotomy procedure to detect middle ear fluid
Secondary Outcome Measures
fluid viscosity
fluid obtained during myringotomy will be tested for viscosity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01421199
Brief Title
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
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 Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OtoSonics Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study has three objectives:
To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy)
If fluid is present to characterize the fluid as thick or thin
Evaluate the safety of the device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion, Middle Ear Effusion
Keywords
Otitis Media with Effusion, Middle Ear Effusion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myringotomy
Arm Type
Other
Arm Description
On arm
Intervention Type
Procedure
Intervention Name(s)
Myringotomy
Other Intervention Name(s)
ear tubes
Intervention Description
tube placement for children with multiple ear infections
Primary Outcome Measure Information:
Title
detection of middle ear fluid
Description
device will be used during myringotomy procedure to detect middle ear fluid
Time Frame
day one
Secondary Outcome Measure Information:
Title
fluid viscosity
Description
fluid obtained during myringotomy will be tested for viscosity
Time Frame
day one
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark E Boseley, MD
Phone
253.968.1430
First Name & Middle Initial & Last Name or Official Title & Degree
Shaun Nguyen, MD
Phone
843.792.1356
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark E Boseley, MD
Organizational Affiliation
Madigan Army Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
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