Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.
For purposes of this clinical study, the Sinopsys Lacrimal Stent is intended to provide a means of administering saline sinus irrigation via a transcaruncular-ethmoid sinus access in patients with moderate to severe chronic rhinosinusitis with ethmoid involvement. The purpose of the administration of saline irrigation is to reduce the intensity of symptoms of chronic rhinosinusitis in this patient population.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinopsys Lacrimal Stent | Experimental | The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinopsys Lacrimal Stent | Device | The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SNOT - 20 | Chronic Rhinosinusitis symptoms as measured by SNOT-20 scores from baseline to 18 weeks follow-up (1, 4, 8, 12, and 18) | 18 Weeks |
| Patency will be confirmed post procedure with passive flow through the SLS lumen by instilling 2-4 drops of sterile saline into the stented medial fornix and observing drainage. | Patients will be trained for self-administration of saline irrigation prior to the discharge home. Subjects will be instructed how to observe for stent patency and to report problems with flow to the Investigator. | 18 Weeks |
| Safety: Incidence and occurrence of anticipated and unanticipated adverse events | Assessment of the incidence and occurrence of anticipated and unanticipated adverse events reported during the 18 weeks of the clinical study. | 18 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lund-MacKay CT Scores | Comparison of baseline and 12 weeks | 12 Weeks |
| Lund-Kennedy Nasal Endoscopy Scores | Comparison of baseline and 12 weeks |
Not provided
Inclusion Criteria:
The Investigator has determined that the potential study subject has moderate to severe chronic rhinosinusitis with ethmoid involvement and has followed at least twelve (12) weeks of appropriate medical therapy prior to enrollment
Age ≥ 22 years
The potential study subject meets the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) criteria for chronic rhinosinusitis 12 weeks or longer of two or more of the following signs and symptoms:
AND inflammation is documented by one or more of the following findings:
SNOT-20 total score ≥ 41
CT scan (coronal view) confirms inflammation / involvement of the ethmoid sinuses
CT scan (coronal view) confirms depth of olfactory fossa is Keros classification 1 or 2.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teena Augustino | Sinopsys Surgical Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Front Range ENT |
Not provided
| ID | Term |
|---|---|
| D015521 | Ethmoid Sinusitis |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 Weeks |
| Greeley |
| Colorado |
| 80634 |
| United States |
| Advanced ENT and Allergy | Louisville | Kentucky | 40207 | United States |
| D009668 |
| Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |