Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00645762
First received: March 20, 2008
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Sinusitis
Device: RS-Series Rhinosinusitis Treatment System
Device: FinESS Balloon
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

Resource links provided by NLM:


Further study details as provided by Entellus Medical, Inc.:

Primary Outcome Measures:
  • Incidences of Device-related or Procedure-related Complications [ Time Frame: Through 12 months post-procedure ] [ Designated as safety issue: Yes ]
  • Patency of the Treated Area as Verified by CT Scan [ Time Frame: Post-treatment at 3 months ] [ Designated as safety issue: No ]
    Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.

  • Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement [ Time Frame: Post-treatment through 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 71
Study Start Date: September 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Balloon Dilation
Balloon dilation with FinESS device
Device: RS-Series Rhinosinusitis Treatment System
Single arm
Device: FinESS Balloon

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645762

Locations
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
Principal Investigator: James Stankiewicz, MD Loyola University Medical Center, Maywood IL
Principal Investigator: Thomas Tami, MD Cincinnati Sinus Institute, Cincinnati OH
  More Information

No publications provided by Entellus Medical, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT00645762     History of Changes
Other Study ID Numbers: 1156-001
Study First Received: March 20, 2008
Results First Received: March 15, 2013
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

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:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014