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

Overview

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

Full Title of Study: “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

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Diagnostic
  • Masking: Single (Investigator)
• Study Primary Completion Date: December 2011

Interventions

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

Arms, Groups and Cohorts

• Other: Myringotomy
  • On arm

Clinical Trial Outcome Measures

Primary Measures

• detection of middle ear fluid
  • Time Frame: day one
  • device will be used during myringotomy procedure to detect middle ear fluid

Secondary Measures

• fluid viscosity
  • Time Frame: day one
  • fluid obtained during myringotomy will be tested for viscosity

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • OtoSonics Inc.
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Mark E Boseley, MD, Principal Investigator, Madigan Army Medical Center
• Overall Contact(s)
  • Mark E Boseley, MD, 253.968.1430