Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium

Completed · Phase 1

Conditions studied: Sinusitis

In brief

The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.

Key facts

Study ID

NCT01623050

Run by

SinuSys Corporation

People needed

36

Starts

2012-04-01

Expected to finish

2014-09-01

Last updated by the study team

2014-11-05

Who can join

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

You may qualify if…

• Diagnosis of chronic maxillary sinusitis

You may not qualify if…

• Previous antrostomy
• Sinonasal tumours
• Cystic fibrosis
• History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus
• Pregnant or breastfeeding females
• Currently participating in another drug or device study

Where it is running

• Valley ENT — Tucson, Arizona, United States
• Palo Alto Medical Foundation — Palo Alto, California, United States
• St. Elizabeth Medical Center — Boston, Massachusetts, United States
• St. Paul's Hospital, ENT Department — Vancouver, British Columbia, Canada
• Charing Cross Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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