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Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00645762
Recruitment Status : Completed
First Posted : March 28, 2008
Results First Posted : July 29, 2013
Last Update Posted : July 29, 2013
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sinusitis Device: RS-Series Rhinosinusitis Treatment System Device: FinESS Balloon Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balloon REmodeling Antrostomy THErapy Study (BREATHE I)
Study Start Date : September 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Balloon Dilation
Balloon dilation with FinESS device
 Device: RS-Series Rhinosinusitis Treatment System
Single arm

Device: FinESS Balloon


Outcome Measures
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Primary Outcome Measures :
  1. Incidences of Device-related or Procedure-related Complications [ Time Frame: Through 12 months post-procedure ]
  2. Patency of the Treated Area as Verified by CT Scan [ Time Frame: Post-treatment at 3 months ]
    Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.

  3. Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement [ Time Frame: Post-treatment through 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645762


Locations
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United States, California
Central California Ear, Nose and Throat Medical Group
Fresno, California, United States, 93720
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Minnesota
St. Cloud Ear, Nose & Throat - Head and Neck Clinic
Saint Cloud, Minnesota, United States, 56303
United States, New York
Otolaryngology-Facial Plastic Surgery of Long Island P.C.
Lake Success, New York, United States, 11042
United States, North Carolina
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, United States, 28210
United States, South Dakota
Midwest Ear, Nose, and Throat
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Austin Ear, Nose & Throat Clinic
Austin, Texas, United States, 78705-1023
Texas Sinus Center
Boerne, Texas, United States, 78006
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, United States, 78229
United States, Washington
Ear, Nose, Throat & Plastic Surgery Associates, PS
Auburn, Washington, United States, 98002
Sponsors and Collaborators
Entellus Medical, Inc.
Investigators
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Principal Investigator: James Stankiewicz, MD Loyola University Medical Center, Maywood, IL
Principal Investigator: Thomas Tami, MD Cincinnati Sinus Institute, Cincinnati OH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT00645762    
Other Study ID Numbers: 1156-001
First Posted: March 28, 2008    Key Record Dates
Results First Posted: July 29, 2013
Last Update Posted: July 29, 2013
Last Verified: June 2013
Keywords provided by Entellus Medical, Inc.:
Chronic rhinosinusitis
Chronic sinusitis
Maxillary sinus
Anterior ethmoid sinus
Ethmoid infundibulum
 Balloon dilation
Endoscopic visualization
Local anesthesia
Canine fossa
Less invasive
Additional relevant MeSH terms:
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Sinusitis
Respiratory Tract Infections
Infections
Paranasal Sinus Diseases
 Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases