The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

Status Completed

Clinical Trial 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 repair of the lacrimal system in patients with functional or obstructive epiphora.

Clinical Trial 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 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Epiphora

Clinical Trial Details

NCT number	NCT02240615
Study type	Interventional
Source	Sinopsys Surgical
Contact
Status	Completed
Phase	Phase 0
Start date	October 2014
Completion date	February 2016

View Details

See also
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