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Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

Primary Purpose

Sinusitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RS-Series Rhinosinusitis Treatment System
FinESS Balloon
Sponsored by
Entellus Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis focused on measuring Chronic rhinosinusitis, Chronic sinusitis, Maxillary sinus, Anterior ethmoid sinus, Ethmoid infundibulum, Balloon dilation, Endoscopic visualization, Local anesthesia, Canine fossa, Less invasive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central California Ear, Nose and Throat Medical Group
  • NorthShore University HealthSystem
  • Loyola University Medical Center
  • St. Cloud Ear, Nose & Throat - Head and Neck Clinic
  • Otolaryngology-Facial Plastic Surgery of Long Island P.C.
  • Charlotte Eye, Ear, Nose & Throat Associates
  • Midwest Ear, Nose, and Throat
  • Holston Medical Group
  • Vanderbilt University Medical Center
  • Austin Ear, Nose & Throat Clinic
  • Texas Sinus Center
  • San Antonio Ear, Nose, and Throat Research
  • Ear, Nose, Throat & Plastic Surgery Associates, PS

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Balloon Dilation

Arm Description

Balloon dilation with FinESS device

Outcomes

Primary Outcome Measures

Incidences of Device-related or Procedure-related Complications
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2008
Last Updated
June 20, 2013
Sponsor
Entellus Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00645762
Brief Title
Balloon REmodeling Antrostomy THErapy Study
Acronym
BREATHE I
Official Title
Balloon REmodeling Antrostomy THErapy Study (BREATHE I)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entellus Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
Chronic rhinosinusitis, Chronic sinusitis, Maxillary sinus, Anterior ethmoid sinus, Ethmoid infundibulum, Balloon dilation, Endoscopic visualization, Local anesthesia, Canine fossa, Less invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon Dilation
Arm Type
Active Comparator
Arm Description
Balloon dilation with FinESS device
Intervention Type
Device
Intervention Name(s)
RS-Series Rhinosinusitis Treatment System
Intervention Description
Single arm
Intervention Type
Device
Intervention Name(s)
FinESS Balloon
Primary Outcome Measure Information:
Title
Incidences of Device-related or Procedure-related Complications
Time Frame
Through 12 months post-procedure
Title
Patency of the Treated Area as Verified by CT Scan
Description
Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.
Time Frame
Post-treatment at 3 months
Title
Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement
Description
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.
Time Frame
Post-treatment through 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Stankiewicz, MD
Organizational Affiliation
Loyola University Medical Center, Maywood, IL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Tami, MD
Organizational Affiliation
Cincinnati Sinus Institute, Cincinnati OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central California Ear, Nose and Throat Medical Group
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
St. Cloud Ear, Nose & Throat - Head and Neck Clinic
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Otolaryngology-Facial Plastic Surgery of Long Island P.C.
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Charlotte Eye, Ear, Nose & Throat Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Midwest Ear, Nose, and Throat
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Austin Ear, Nose & Throat Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-1023
Country
United States
Facility Name
Texas Sinus Center
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
San Antonio Ear, Nose, and Throat Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Ear, Nose, Throat & Plastic Surgery Associates, PS
City
Auburn
State/Province
Washington
ZIP/Postal Code
98002
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19419611
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.
Results Reference
derived

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Balloon REmodeling Antrostomy THErapy Study

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