NCT03304951

Sinopsys® Lacrimal Stent Indicated for Sinus Irrigation

Interventioanl Study of the Sinopsys® Lacrimal Stent in Patients With Moderate to Severe Chronic Rhinosinusitis to Evaluate Safety and Performance for Direct Ethmoid Sinus Saline Irrigation and Ophthalmic Antibiotic/Steroid Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Sinopsys Surgical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate clinical data related to the safety and performance of the Sinopsys® Lacrimal Stent.

Detailed description

The primary objective of this study is to evaluate the safety and performance of the Sinopsys® Lacrimal Stent in the treatment of patients with moderate to severe chronic chronic rhinosinusitis via direct ethmoid sinus saline irrigation and delivery of an ophthalmic antibiotic/steroid drug.

Conditions

• Ethmoid Sinusitis

Interventions

Type	Name	Description
DEVICE	Sinopsys® Lacrimal Stent	The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid access.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2017-10-09
• Last updated: 2018-09-06

Locations

1 site across 1 country: Czechia