Trials / Completed
CompletedNCT00939796
Clinical Study of the Tympanostomy Tube Delivery System
A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media (inVENT)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube \[TT(s)\] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Acclarent Tympanostomy Tube Delivery System | A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2009-06-01
- Completion
- 2009-07-01
- First posted
- 2009-07-15
- Last updated
- 2024-08-06
- Results posted
- 2014-06-09
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00939796. Inclusion in this directory is not an endorsement.