Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

Entellus Medical

Status and phase

Completed

Phase 2

Conditions

Sinusitis

Treatments

Device: FinESS Balloon

Device: RS-Series Rhinosinusitis Treatment System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00645762

1156-001

Details and patient eligibility

About

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.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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:
1. 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.
2. Evidence of maxillary sinus air/liquid level.

Exclusion criteria

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