The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Sinopsys Lacrimal Stent Used During the Repair of the Lacrimal System in Patients With Epiphora

Conditions
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Epiphora

Intervention / Treatment
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* Device: Sinopsys Lacrimal Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically significant functional epiphora for at least three months Keros classification 1 or 2 skull base anatomy Exclusion Criteria: Active infection Craniofacial deformity Severe inflammatory disease

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sinopsys Lacrimal Stent<br>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. | Device: Sinopsys Lacrimal Stent<br>* Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epiphora, Lacrimal Stent, Lacrimal System