Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02087150
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter
Sponsor:
Integra LifeSciences Corporation
Organization:
Study Overview
Official Title:
A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)
Status:
COMPLETED
Status Verified Date:
2024-07
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:
ELLIOTT
Brief Summary:
The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: