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

March 20, 2008
June 20, 2013
September 2007
June 2010   (final data collection date for primary outcome measure)
  • 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.
  • Incidences of device-related or procedure-related complications [ Time Frame: Post-treatment through 12 months ] [ 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 ]
  • Change in Sino Nasal Outcome Test (SNOT-20) scores [ Time Frame: Post-treatment at 1 week, 4 weeks, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00645762 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Balloon REmodeling Antrostomy THErapy Study
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sinusitis
  • Device: RS-Series Rhinosinusitis Treatment System
    Single arm
  • Device: FinESS Balloon
Active Comparator: Balloon Dilation
Balloon dilation with FinESS device
Interventions:
  • Device: RS-Series Rhinosinusitis Treatment System
  • Device: FinESS Balloon
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. Epub 2009 Jan 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00645762
1156-001
No
Entellus Medical, Inc.
Entellus Medical, Inc.
Not Provided
Principal Investigator: James Stankiewicz, MD Loyola University Medical Center, Maywood IL
Principal Investigator: Thomas Tami, MD Cincinnati Sinus Institute, Cincinnati OH
Entellus Medical, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP