Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393900
Status:
COMPLETED
Last Update Posted:
2017-10-19
First Post:
2006-10-30
Brief Title:
Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
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:
This study will determine if the investigators can use certain tests eustachian tube function tests and gas exchange tests to predict whether or not a child who had tubes surgically placed in their eardrum because of middle-ear disease will redevelop the disease again after the tubes quit working
Detailed Description:
This study will enroll children 3-6 years of age with tympanostomy tubes inserted for otitis media with effusion OMEand measure middle ear gas demand middle ear volume and eustachian tube function longitudinally between the time of tube insertion and extrusionnonfunctioning The data will be used to test the hypotheses that gas transfer across the middle ear mucosa decreases in phase with resolution of middle ear inflammation and effusion gas transfer across the middle ear mucosa is increased by an episode of otorrhea eustachian tube function is unaffected by tympanostomy tube insertion and measurement of eustachian tube function and trans-middle ear mucosa gas transfer predicts disease recurrence and presentation after tube extrusionnonfunctioning The results of these studies will be used to support or refute tested components of existing models of middle ear pressure-regulation and to develop test protocols for risk assignments with respect to disease recurrence in individual ears after tympanostomy tube extrusionnonfunctioning
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH 1P50DC007667 | None | None | None |