Phase 1
N=36
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT01623050 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Patency of Treated Area — 95 percentage of ostia treated
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- SinuSys Dilation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SinuSys Corporation
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patency of Treated Area |
93 | — |
| SECONDARY Patency of Treated Area |
93 | — |
| SECONDARY Number of Participants With Device-related Adverse Events as a Measure of Safety |
— | — |
| SECONDARY Patency of Treated Area |
93 | — |
| SECONDARY Patency of Treated Area |
93 | — |
Summary
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01623050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.