Balloon REmodeling Antrostomy THErapy Study

Sinusitis Clinical Trial

— BREATHE I  

Official title:

Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645762
• Other study ID #: 1156-001
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2008
• Last updated: June 20, 2013
• Start date: September 2007
• Est. completion date: June 2010

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sinusitis

Intervention

Device:
• RS-Series Rhinosinusitis Treatment System
Single arm
• FinESS Balloon

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Entellus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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