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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01421199
Other study ID # OTO-Myr
Secondary ID
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


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
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