Clinical Trial: Sinopsys Lacrimal Stent Indicated for Sinus Irrigation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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

Detailed Summary: 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.
Sponsor: Sinopsys Surgical

Current Primary Outcome:

• SNOT - 20 [ Time Frame: 18 Weeks ]
  Chronic Rhinosinusitis symptoms as measured by SNOT-20 scores from baseline to 18 weeks follow-up (1, 4, 8, 12, and 18)
• Patency will be confirmed post procedure with passive flow through the SLS lumen by instilling 2-4 drops of sterile saline into the stented medial fornix and observing drainage. [ Time Frame: 18 Weeks ]
  Patients will be trained for self-administration of saline irrigation prior to the discharge home. Subjects will be instructed how to observe for stent patency and to report problems with flow to the Investigator.
• Safety: Incidence and occurrence of anticipated and unanticipated adverse events [ Time Frame: 18 Weeks ]
  Assessment of the incidence and occurrence of anticipated and unanticipated adverse events reported during the 18 weeks of the clinical study.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Lund-MacKay CT Scores [ Time Frame: 12 Weeks ]
  Comparison of baseline and 12 weeks
• Lund-Kennedy Nasal Endoscopy Scores [ Time Frame: 12 Weeks ]
  Comparison of baseline and 12 weeks

Original Secondary Outcome: Same as current

Information By: Sinopsys Surgical

Dates:
Date Received: November 14, 2014
Date Started: March 2015
Date Completion:
Last Updated: February 11, 2016
Last Verified: February 2016