Balloon REmodeling Antrostomy THErapy Study

Completed · Phase 2

Conditions studied: Sinusitis

In brief

This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.

Key facts

Study ID

NCT00645762

Run by

Entellus Medical, Inc.

People needed

71

Starts

2007-09-01

Expected to finish

2010-06-01

Last updated by the study team

2013-07-29

Who can join

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

You may qualify if…

• Subjects age 18 or older with chronic rhinosinusitis of the maxillary or maxillary and anterior ethmoid sinuses
• A CT scan taken after maximal medical therapy (e.g., local or systemic antibiotics, topical steroids, etc.) must show one of the following:
• Narrowing of the outflow tract of the maxillary sinus ostium or infundibulum with mucosal thickening of 2 mm or greater of the maxillary sinus antrum.
• Evidence of maxillary sinus air/liquid level.

You may not qualify if…

• Evidence of chronic posterior ethmoid, sphenoid or frontal sinusitis
• Inability to understand the study or a history of non-compliance with medical advice
• Unwilling or unable to sign Informed Consent Form (ICF)
• Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies)
• History of any cognitive or mental health status that would interfere with study participation
• Previous sinus surgery or intervention including sinuplasty
• Pregnant women
• Severe septal deviation causing obstruction of the ostiomeatal unit
• History of primary ciliary dysfunction
• Hemophilia
• Currently undergoing or in the past 6 months had undergone chemotherapy for cancer or radiation therapy in the head or neck region
• History of cystic fibrosis
• Known Sampter's Triad (aspirin sensitivity, asthma, sinonasal polyposis)
• Known sinonasal tumors or obstructive lesions
• History of mid facial fractures or orthognathic surgery (does not include nasal fracture)
• History of insulin dependent diabetes
• Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio(INR) is below 1.5
• Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure
• Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure
• Presence of nasal polyps that may interfere with the treatment procedure
• Presence of features consistent with sinus fungal disease on CT or physical examination

Where it is running

• Central California Ear, Nose and Throat Medical Group — Fresno, California, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• St. Cloud Ear, Nose & Throat - Head and Neck Clinic — Saint Cloud, Minnesota, United States
• Otolaryngology-Facial Plastic Surgery of Long Island P.C. — Lake Success, New York, United States
• Charlotte Eye, Ear, Nose & Throat Associates — Charlotte, North Carolina, United States
• Midwest Ear, Nose, and Throat — Sioux Falls, South Dakota, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Austin Ear, Nose & Throat Clinic — Austin, Texas, United States
• Texas Sinus Center — Boerne, Texas, United States
• San Antonio Ear, Nose, and Throat Research — San Antonio, Texas, United States
• Ear, Nose, Throat & Plastic Surgery Associates, PS — Auburn, Washington, United States

Full record on ClinicalTrials.gov

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