Status:
COMPLETED
The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora
Lead Sponsor:
Sinopsys Surgical
Conditions:
Epiphora
Eligibility:
All Genders
22+ years
Phase:
EARLY_PHASE1
Brief Summary
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 repai...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Clinically significant functional epiphora for at least three months
- Keros classification 1 or 2 skull base anatomy
Exclusion
- Active infection
- Craniofacial deformity
- Severe inflammatory disease
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02240615
Start Date
October 1 2014
End Date
February 1 2016
Last Update
February 12 2016
Active Locations (4)
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1
Stanford University
Stanford, California, United States, 94305
2
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
3
Center for Sight
Sarasota, Florida, United States, 34239
4
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704