Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741333
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-02-14
Brief Title:
In-Office Clinical Study of the Solo TTD
Sponsor:
AventaMed DAC
Organization:
AventaMed DAC
Study Overview
Official Title:
Pivotal In-Office Clinical Study of the Solo Tympanostomy Tube Device
Status:
RECRUITING
Status Verified Date:
2024-01
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:
VENTY
Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of the Solo Tympanostomy Tube Device Solo TTD for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure
Detailed Description:
The study will be a multi-site prospective treatment-only study to gather safety and effectiveness data on the use of the Solo TTD in-office with topical anesthesia in children aged 6 months to 13 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None