Trials / Completed
CompletedNCT01444391
inVENT-visIOn Study
A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tympanostomy tube placement (Acclarent iontophoresis device) | Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2012-05-01
- Completion
- 2012-06-01
- First posted
- 2011-09-30
- Last updated
- 2024-07-12
- Results posted
- 2014-09-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01444391. Inclusion in this directory is not an endorsement.