NCT02297243

Sinopsys Lacrimal Stent Indicated for Sinus Irrigation

The Sinopsys Lacrimal Stent Indicated for Sinus Irrigation Via Transcaruncular Ethmoid Sinus Access in Patients With Moderate to Severe Chronic Rhinosinusitis With Ethmoid Sinus Involvement

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sinopsys Surgical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.

Detailed description

For purposes of this clinical study, the Sinopsys Lacrimal Stent is intended to provide a means of administering saline sinus irrigation via a transcaruncular-ethmoid sinus access in patients with moderate to severe chronic rhinosinusitis with ethmoid involvement. The purpose of the administration of saline irrigation is to reduce the intensity of symptoms of chronic rhinosinusitis in this patient population.

Conditions

• Ethmoid Sinusitis

Interventions

Type	Name	Description
DEVICE	Sinopsys Lacrimal Stent	The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-11-21
• Last updated: 2016-02-12

Locations

3 sites across 1 country: United States