SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

Completed · Not applicable

Conditions studied: Sinusitis

In brief

The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.

Key facts

Study ID

NCT02463279

Run by

SinuSys Corporation

People needed

30

Starts

2015-04-01

Expected to finish

2016-03-01

Last updated by the study team

2016-12-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of CRS
• Subject in in need of frontal recess and/or sphenoid sinus dilation

You may not qualify if…

• Pregnant or breastfeeding females
• Previous treatment site intervention
• Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation

Where it is running

• Upland ENT — Upland, California, United States
• Colorado ENT — Denver, Colorado, United States
• St. Elizabeth Medical Center — Brighton, Massachusetts, United States

Full record on ClinicalTrials.gov

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