Clinical trial NCT00645762: Balloon REmodeling Antrostomy THErapy Study
Official title: Balloon REmodeling Antrostomy THErapy Study (BREATHE I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sinusitis
Keywords: Chronic rhinosinusitis
Chronic sinusitis
Maxillary sinus
Anterior ethmoid sinus
Ethmoid infundibulum
Balloon dilation
Endoscopic visualization
Local anesthesia
Canine fossa
Less invasive
Lead sponsor: Entellus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidences of Device-related or Procedure-related Complications
timeFrame: Through 12 months post-procedure
measure: Patency of the Treated Area as Verified by CT Scan
timeFrame: Post-treatment at 3 months
measure: Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement
timeFrame: Post-treatment through 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central California Ear, Nose and Throat Medical Group
state: California
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Saint Cloud
country: United States
facility: St. Cloud Ear, Nose & Throat - Head and Neck Clinic
state: Minnesota
city: Lake Success
country: United States
facility: Otolaryngology-Facial Plastic Surgery of Long Island P.C.
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Associates
state: North Carolina
city: Sioux Falls
country: United States
facility: Midwest Ear, Nose, and Throat
state: South Dakota
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Ear, Nose & Throat Clinic
state: Texas
city: Boerne
country: United States
facility: Texas Sinus Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Ear, Nose, and Throat Research
state: Texas
city: Auburn
country: United States
facility: Ear, Nose, Throat & Plastic Surgery Associates, PS
state: Washington
Study officials:
affiliation: Loyola University Medical Center, Maywood, IL
name: James Stankiewicz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cincinnati Sinus Institute, Cincinnati OH
name: Thomas Tami, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stankiewicz J, Tami T, Truitt T, Atkins J, Liepert D, Winegar B. Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. Am J Rhinol Allergy. 2009 May-Jun;23(3):321-7. doi: 10.2500/ajra.2009.23.3274. Epub 2009 Jan 16.