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

OtoSonics

Status: Unknown

Conditions: Otitis Media With Effusion; Middle Ear Effusion

Treatments: Procedure: Myringotomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01421199

OTO-Myr

Details and patient eligibility

About

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

Enrollment: 125 estimated patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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125 participants in 1 patient group

Myringotomy

Other group

Description:

On arm

Treatment:

Procedure: Myringotomy