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

NCT01421199 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2011-08-22

No results posted yet for this study

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

Conditions

  • Otitis Media With Effusion
  • Middle Ear Effusion

Interventions

PROCEDURE

Myringotomy

tube placement for children with multiple ear infections

Sponsors & Collaborators

  • OtoSonics Inc.

    lead INDUSTRY

Principal Investigators

  • Mark E Boseley, MD · Madigan Army Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01421199 on ClinicalTrials.gov