XprESS Maxillary Balloon Dilation Study

Completed · Not applicable

Conditions studied: Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

In brief

A prospective, single-arm, post approval pilot study.

Key facts

Study ID

NCT01525862

Run by

Entellus Medical, Inc.

People needed

21

Starts

2011-12-01

Expected to finish

2013-01-01

Last updated by the study team

2020-11-10

Who can join

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

You may qualify if…

• Be at least 18 years of age.
• Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease.
• Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis.
• Have a CT scan within 6 months prior to enrollment.
• Be mentally and physically capable (as per physician discretion) to participate in the investigation.
• Be willing and able to sign the study-specific informed consent prior to any study-related procedures.
• Be willing and able to undergo balloon dilation in the clinic setting.

You may not qualify if…

• Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation.
• Have presence of features consistent with sinus fungal disease.
• Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum.
• Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc).
• Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty).
• Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment.
• Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract.
• Have a history of primary ciliary dysfunction.
• Have hemophilia.
• Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region.
• Have a history of cystic fibrosis.
• Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis).
• Have known sinonasal tumors or obstructive lesions.
• Be pregnant at the time of enrollment.
• Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5.
• Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure.
• 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
• Synergy ENT Specialists — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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