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

Otitis Media With Effusion Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01421199
• Other study ID #: OTO-Myr
• Status: Not yet recruiting
• Phase: N/A
• First received: August 18, 2011
• Last updated: August 19, 2011
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2011
• Source: OtoSonics Inc.
• Contact: Mark E Boseley, MD
• Phone: 253.968.1430
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Middle Ear Effusion
• Otitis Media
• Otitis Media with Effusion

Intervention

Procedure:
• Myringotomy
tube placement for children with multiple ear infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OtoSonics Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of middle ear fluid	device will be used during myringotomy procedure to detect middle ear fluid	day one	No
Secondary	fluid viscosity	fluid obtained during myringotomy will be tested for viscosity	day one	No