NCT00645762
Balloon REmodeling Antrostomy THErapy Study
PHASE2
COMPLETED
NCT00645762
INTERVENTIONAL
Balloon REmodeling Antrostomy THErapy Study (BREATHE I)
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.
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
Sinusitis
- TREATMENT
-
- Type: DEVICE
- Name: RS-Series Rhinosinusitis Treatment System
- Description: Single arm
- Arm Group Labels: Balloon Dilation
-
- Type: DEVICE
- Name: FinESS Balloon
- Description:
- Arm Group Labels: Balloon Dilation
- Entellus Medical, Inc.