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Prospective, open label, multi-center, non-randomized study designed to collect initial clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system in patients with functional or obstructive epiphora.
Up to 10 patients will be enrolled and followed for six months. The primary objective is to demonstrate the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system for ethmoid sinus intubation and bypass to canalicular pathologies in this patient population. The primary outcome measure for performance is the relief of epiphora determined by both investigator assessment of stent patency and patient self-assessment of epiphora symptom improvement compared to baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinopsys Lacrimal Stent | Experimental | All enrolled patients will receive a Sinopsys Lacrimal Stent inserted from the caruncle to the ethmoid sinus. Discharge instructions will include administration of sterile saline and ophthalmic drops as well as assessments for device patency. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinopsys Lacrimal Stent | Device | Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief of epiphora, determined by both 1) the Investigator assessment of the patency/function of the Sinopsys Lacrimal Stent ( and 2) the subject's self-assessment of tearing. | PI self assessment of stent patency and patient self assessment of improvement of epiphora symptoms compared to baseline | Six Months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of device insertion success | Procedural | |
| Evaluation of all safety | Recording of all safety events that occur in the first six months of treatment | Six Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Ross, MD | Sinopsys Surgical Inc. | Study Director |
| Teena Augostino | Sinopsys Surgical Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| University of Colorado Health Sciences Center |
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| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Aurora |
| Colorado |
| 80045 |
| United States |
| Center for Sight | Sarasota | Florida | 34239 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |