NCT03066908

Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS

A Prospective, Single Arm, Multicenter Study of the Sinopsys® Lacrimal Stent Used for Transcaruncular-Ethmoid Sinus Access and Saline Irrigation in Patients With Moderate to Severe Chronic Rhinosinusitis

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Sinopsys Surgical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single arm, multicenter study designed to demonstrate that the Sinopsys® Lacrimal Stent can safely create transcaruncular access to the ethmoid sinus to enable sinus irrigation and reduce symptoms in patients with moderate to severe chronic rhinosinusitis.

Conditions

• Chronic Sinus Infection

Interventions

Type	Name	Description
DEVICE	Sinopsys® Lacrimal Stent	Transcaruncular paranasal sinus or nasal cavity access for the purpose of irrigating the ethmoid sinus with saline

Timeline

• Start date: 2017-04-20
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2017-03-01
• Last updated: 2023-09-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study