NCT02240615

The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sinopsys Surgical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Epiphora

Interventions

Type	Name	Description
DEVICE	Sinopsys Lacrimal Stent	Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-09-15
• Last updated: 2016-02-12

Locations

4 sites across 1 country: United States