Trials / Unknown
UnknownNCT01421199
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 125 (estimated)
- Sponsor
- OtoSonics Inc. · Industry
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Myringotomy | tube placement for children with multiple ear infections |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2011-08-22
- Last updated
- 2011-08-22
Source: ClinicalTrials.gov record NCT01421199. Inclusion in this directory is not an endorsement.