Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
| Status: | Recruiting |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/3/2014 |
| Start Date: | April 2012 |
| Contact: | Janie Mandrusov, Ph.D. |
| Email: | emandrusov@sinusys.com |
| Phone: | 408-410-4411 |
SinuSys Patency of Maxillary Sinus Ostia Study
The purpose of this study is to assess safety and performance of the SinuSys Dilation
System for dilation of the maxillary sinus ostium.
System for dilation of the maxillary sinus ostium.
Inclusion Criteria:
-Diagnosis of chronic maxillary sinusitis
Exclusion Criteria:
- Previous antrostomy
- Sinonasal tumours
- Cystic fibrosis
- History of facial trauma that distorts sinus anatomy and precludes access to the
maxillary sinus
- Pregnant or breastfeeding females
- Currently participating in another drug or device study
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