Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-02 @ 6:23 PM
Study NCT ID:
NCT03722160
Status:
UNKNOWN
Last Update Posted:
2019-10-28
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of the Solo Tympanostomy Tube Device
Sponsor:
AventaMed DAC
Organization:
Study Overview
Official Title:
Clinical Study of the Solo Tympanostomy Tube Device
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
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 objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
Detailed Description:
The study will be a multi-site, prospective, treatment-only study of the Solo Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: