Trials / Completed
CompletedNCT02463279
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- SinuSys Corporation · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.
Detailed description
A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sinusys Dilation System | Dilation of frontal recess and/or sphenoid sinus ostia |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2015-10-01
- Completion
- 2016-03-01
- First posted
- 2015-06-04
- Last updated
- 2016-12-13
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02463279. Inclusion in this directory is not an endorsement.