XprESS Registry Study

Completed · Not applicable

Conditions studied: Sinusitis

In brief

This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).

Key facts

Study ID

NCT01115309

Run by

Entellus Medical, Inc.

People needed

175

Starts

2010-04-01

Expected to finish

2011-12-01

Last updated by the study team

2020-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
• Willing and able to provide consent

You may not qualify if…

• Known Samter's Triad
• History of primary ciliary dysfunction
• History of cystic fibrosis
• Known to be immunosuppressed
• Hemophilia
• Currently enrolled in another pre-approval investigational study

Where it is running

• Texas Sinus Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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