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

August 19, 2011 updated by: OtoSonics Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Myringotomy
On arm
Procedure: Myringotomy
tube placement for children with multiple ear infections
Other Names:
  • ear tubes

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fluid viscosity
Time Frame: day one
fluid obtained during myringotomy will be tested for viscosity
day one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OtoSonics Inc.

Investigators

  • Principal Investigator: Mark E Boseley, MD, Madigan Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 22, 2011

Study Record Updates

Last Update Posted (Estimate)

August 22, 2011

Last Update Submitted That Met QC Criteria

August 19, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTO-Myr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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