Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Completed · Not applicable

Conditions studied: Sinusitis

In brief

The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.

Key facts

Study ID

NCT01612780

Run by

Entellus Medical, Inc.

People needed

82

Starts

2012-04-01

Expected to finish

2013-10-01

Last updated by the study team

2020-10-22

Who can join

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

You may qualify if…

• Be at least age 18 years old or older.
• Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use.
• Have a sinus CT scan within 12 months of the procedure date.
• Be able and willing to provide consent.
• Be willing to comply with the protocol requirements.

You may not qualify if…

• Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).
• Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.
• Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.
• Have presence of features consistent with sinus fungal disease.
• Be allergic to nickel or barium sulfate.
• Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Where it is running

• Entellus Medical — Plymouth, Minnesota, United States

Full record on ClinicalTrials.gov

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