Sinusitis
Conditions
Brief 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).
Interventions
DEVICESinusys Dilation System
Dilation of frontal recess and/or sphenoid sinus ostia
Sponsors
SinuSys Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of CRS * Subject in in need of frontal recess and/or sphenoid sinus dilation
Exclusion criteria
* Pregnant or breastfeeding females * Previous treatment site intervention * Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency of treated target site | Patency immediately post device expansion and removal | Patency assessed by investigator via endoscopic evaluation of the target site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patency of treated target site | 1 month and 3 months | Patency assessed by investigator via endoscopic evaluation of the target site |
| Reports of sinus related adverse events during the 3 months follow-up period | up to 3 months | — |
Countries
United States
Outcome results
None listed