Trials / Completed
CompletedNCT01623050
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
SinuSys Patency of Maxillary Sinus Ostia Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- SinuSys Corporation · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
Detailed description
A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SinuSys Dilation System | Sinuplasty |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2013-06-01
- Completion
- 2014-09-01
- First posted
- 2012-06-19
- Last updated
- 2014-11-05
- Results posted
- 2014-10-01
Locations
5 sites across 3 countries: United States, Canada, United Kingdom
Source: ClinicalTrials.gov record NCT01623050. Inclusion in this directory is not an endorsement.