Trials / Completed
CompletedNCT01496287
Tympanostomy Tube Placement in Children in the Office (Inova Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 6 Months – 21 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tube Delivery System (TDS) | Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2012-04-01
- Completion
- 2012-04-01
- First posted
- 2011-12-21
- Last updated
- 2024-08-06
- Results posted
- 2014-07-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01496287. Inclusion in this directory is not an endorsement.