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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01421199

Enrollment

125

Registered

2011-08-22

Start date

2011-09-30

Completion date

2011-12-31

Last updated

2011-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Middle Ear Effusion, Otitis Media With Effusion

Keywords

Otitis Media with Effusion, Middle Ear Effusion

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

Interventions

PROCEDUREMyringotomy

tube placement for children with multiple ear infections

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
detection of middle ear fluid	day one	device will be used during myringotomy procedure to detect middle ear fluid

Secondary

Measure	Time frame	Description
fluid viscosity	day one	fluid obtained during myringotomy will be tested for viscosity

Contacts

Primary ContactMark E Boseley, MD

253.968.1430

Backup ContactShaun Nguyen, MD

843.792.1356

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026