SinusitisPhase 2BREATHE INCT00645762
Balloon REmodeling Antrostomy THErapy Study
A Phase 2 study testing RS-Series Rhinosinusitis Treatment System and FinESS Balloon in people with Sinusitis, run by Entellus Medical, Inc. at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- RS-Series Rhinosinusitis Treatment System and FinESS Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 2007to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Ear, Nose, Throat & Plastic Surgery Associates, PS
Auburn, Washington, 98002
Austin Ear, Nose & Throat Clinic
Austin, Texas, 78705-1023
Texas Sinus Center
Boerne, Texas, 78006
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, 28210
NorthShore University HealthSystem
Evanston, Illinois, 60201
Central California Ear, Nose and Throat Medical Group
Fresno, California, 93720
Holston Medical Group
Kingsport, Tennessee, 37660
Otolaryngology-Facial Plastic Surgery of Long Island P.C.
Lake Success, New York, 11042
Loyola University Medical Center
Maywood, Illinois, 60153
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
St. Cloud Ear, Nose & Throat - Head and Neck Clinic
Saint Cloud, Minnesota, 56303
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, 78229
Midwest Ear, Nose, and Throat
Sioux Falls, South Dakota, 57108
About this study
Official title: 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.
- Conditions
- Sinusitis
- Being tested
- RS-Series Rhinosinusitis Treatment System, FinESS Balloon
- Keywords
- Chronic rhinosinusitis, Chronic sinusitis, Maxillary sinus, Anterior ethmoid sinus, Ethmoid infundibulum, Balloon dilation, Endoscopic visualization, Local anesthesia, Canine fossa, Less invasive
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS-Series Rhinosinusitis Treatment SystemDevice
Single arm
FinESS BalloonDevice
| Study group | Role | What they receive |
|---|---|---|
| Balloon Dilation | Active comparator | Balloon dilation with FinESS device Receives: Device: RS-Series Rhinosinusitis Treatment System; Device: FinESS Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of Device-related or Procedure-related Complications
Measured: Through 12 months post-procedure
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.
Measured: Post-treatment at 3 months
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.
Measured: Post-treatment through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entellus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Stankiewicz, MD, Principal investigator, Loyola University Medical Center, Maywood, ILThomas Tami, MD, Principal investigator, Cincinnati Sinus Institute, Cincinnati OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645762
- Sponsor's protocol ID
- 1156-001
- Acronym
- BREATHE I
- Status last verified
- Jun 2013
- First submitted
- 20 Mar 2008
- Last updated
- 29 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19419611
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon REmodeling Antrostomy THErapy Study (BREATHE I)
- ClinicalTrials.gov ID
- NCT00645762
- Acronym / sponsor ID
- BREATHE I / 1156-001
- Conditions
- Sinusitis
- Keywords
- Chronic rhinosinusitis, Chronic sinusitis, Maxillary sinus, Anterior ethmoid sinus, Ethmoid infundibulum, Balloon dilation, Endoscopic visualization, Local anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Entellus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Posted 29 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balloon Dilation | Active comparator | Device: RS-Series Rhinosinusitis Treatment System, Device: FinESS BalloonBalloon dilation with FinESS device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RS-Series Rhinosinusitis Treatment SystemSingle arm | Device | Balloon Dilation |
| FinESS Balloon | Device | Balloon Dilation |
Primary outcome
Incidences of Device-related or Procedure-related Complications
Time frame: Through 12 months post-procedure
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19419611Stankiewicz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Stankiewicz, MD principal investigator
Loyola University Medical Center, Maywood, IL
Thomas Tami, MD principal investigator
Cincinnati Sinus Institute, Cincinnati OH
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RS-Series Rhinosinusitis Treatment System and FinESS Balloon in people with Sinusitis, run by Entellus Medical, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of Device-related or Procedure-related Complications (time frame: Through 12 months post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00645762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.