Sinusitis
Conditions
Brief 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
Interventions
DEVICESinuSys Dilation System
Sinuplasty
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency of Treated Area | Immediately post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device-related Adverse Events as a Measure of Safety | 3 months | — |
| Patency of Treated Area | 3 months | Maxillary Sinus Ostia Patency of 33 patients analyzed. |
Countries
Canada, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SinuSys Dilation System Maxillary Sinus Dilation
SinuSys Dilation System: Sinuplasty | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | SinuSys Dilation System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 45.1 years STANDARD_DEVIATION 16.1 |
| Region of Enrollment Canada | 12 participants |
| Region of Enrollment United Kingdom | 1 participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Patency of Treated Area
Time frame: Immediately post procedure
Population: Number of osita treated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SinuSys Dilation System | Patency of Treated Area | 95 percentage of ostia treated |
Secondary
Number of Participants With Device-related Adverse Events as a Measure of Safety
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SinuSys Dilation System | Number of Participants With Device-related Adverse Events as a Measure of Safety | 0 number of participants |
Secondary
Patency of Treated Area
Maxillary Sinus Ostia Patency of 33 patients analyzed.
Time frame: 3 months
Population: One patient was lost to follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SinuSys Dilation System | Patency of Treated Area | 93 percentage of ostia patent |
Secondary
Patency of Treated Area
Maxillary Sinus Ostia Patency of 29 patients analyzed.
Time frame: 6 months
Population: 5 patients were lost to follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SinuSys Dilation System | Patency of Treated Area | 91 percentage of ostia patent |
Secondary
Patency of Treated Area
Maxillary Sinus Ostia of 27 patients analyzed.
Time frame: 12 months
Population: 7 patients were lost to follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SinuSys Dilation System | Patency of Treated Area | 93 percentage of ostia patent |