Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01421199
Status:
UNKNOWN
Last Update Posted:
2011-08-22
First Post:
2011-08-18
Brief Title:
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
Sponsor:
OtoSonics Inc
Organization:
OtoSonics Inc
Study Overview
Official Title:
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
Status Verified Date:
2011-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None