Sinusitis Clinical Trial
— BREATHE IOfficial title:
Balloon REmodeling Antrostomy THErapy Study (BREATHE I)
Verified date | June 2013 |
Source | Entellus Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ear, Nose, Throat & Plastic Surgery Associates, PS | Auburn | Washington |
United States | Austin Ear, Nose & Throat Clinic | Austin | Texas |
United States | Texas Sinus Center | Boerne | Texas |
United States | Charlotte Eye, Ear, Nose & Throat Associates | Charlotte | North Carolina |
United States | NorthShore University HealthSystem | Evanston | Illinois |
United States | Central California Ear, Nose and Throat Medical Group | Fresno | California |
United States | Holston Medical Group | Kingsport | Tennessee |
United States | Otolaryngology-Facial Plastic Surgery of Long Island P.C. | Lake Success | New York |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | St. Cloud Ear, Nose & Throat - Head and Neck Clinic | Saint Cloud | Minnesota |
United States | San Antonio Ear, Nose, and Throat Research | San Antonio | Texas |
United States | Midwest Ear, Nose, and Throat | Sioux Falls | South Dakota |
Lead Sponsor | Collaborator |
---|---|
Entellus Medical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidences of Device-related or Procedure-related Complications | Through 12 months post-procedure | Yes | |
Primary | Patency of the Treated Area as Verified by CT Scan | Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians. | Post-treatment at 3 months | No |
Primary | Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement | Symptomatic change in SNOT 20 scores on a 5-point Likert scale where "0" = no problem to "5" = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful. | Post-treatment through 12 months | No |
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