Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
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
1 other identifier
interventional
125
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2011
CompletedFirst Posted
Study publicly available on registry
August 22, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedAugust 22, 2011
August 1, 2011
3 months
August 18, 2011
August 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
detection of middle ear fluid
device will be used during myringotomy procedure to detect middle ear fluid
day one
Secondary Outcomes (1)
fluid viscosity
day one
Study Arms (1)
Myringotomy
OTHEROn arm
Interventions
tube placement for children with multiple ear infections
Eligibility Criteria
You may qualify if:
- months to 17 years
- scheduled to undergo myringotomy procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OtoSonics Inc.lead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark E Boseley, MD
Madigan Army Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2011
First Posted
August 22, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
August 22, 2011
Record last verified: 2011-08