Recurrent Acute RhinosinusitisCABERNETNCT01714687
Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)
A study testing balloon sinus dilation and medical therapy in people with Recurrent Acute Rhinosinusitis, run by Integra LifeSciences Corporation at 5 sites in United States.
Trial summary
This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Recurrent Acute Rhinosinusitis
- What is being tested?
- balloon sinus dilation and medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2012to 1 Apr 2016
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years of age or greater
- diagnosis of recurrent acute rhinosinusitis
- suitable candidate for office-based procedure
- willing and able to read and sign informed consent and remain compliant with protocol and study procedures
- able to read and understand English
Who cannot join
- diagnosis of chronic rhinosinusitis
- prior sinus surgery
- physician determined need for ancillary procedures
- known immune deficiency, ciliary dysfunction and/or autoimmune disease
- clinically significant illness that may interfere with evaluation of the study
- participation in clinical studies 6 months prior to study participation
- pregnant or lactating females
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Atlanta, Georgia, 30342
Study site
Birmingham, Alabama, 35242
Study site
Dallas, Texas, 75231
Study site
Las Vegas, Nevada, 89113
Study site
McKinney, Texas, 75070
About this study
Official title: Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)
This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.
- Conditions
- Recurrent Acute Rhinosinusitis
- Being tested
- balloon sinus dilation, medical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon sinus dilationDevice
Also called balloon sinuplasty
medical therapyOther
Also called medical management
| Study group | Role | What they receive |
|---|---|---|
| balloon sinus dilation | Active comparator | Balloon sinus dilation will be conducted in-office under local anesthesia. Receives: Device: balloon sinus dilation; Other: medical therapy |
| medical therapy | Active comparator | Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment. Receives: Other: medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSS Total Score Change From Baseline to 24 Week Visit
The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include "0 Weeks" (minimum), "1-2 Weeks", "3-4 Weeks", "5-6 Weeks", and "7-8 Weeks" (maximum).
The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes.
The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only.
Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).
Higher score indicates greater improvement.
Measured: 24 Week Visit
Secondary outcomes (8)
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks
The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("0 Weeks" (minimum) to "7-8 Weeks" (maximum)) used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores over 24 and 48 weeks, and average total CSS score over 48 weeks for subjects randomized to BSD versus medical management. Higher score indicates greater improvement.
Measured: 8, 16, 24, 32, 40, and 48 Weeks
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks
The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values include "Never" (minimum), "Almost Never", "Sometimes", "Almost Always", "Always" (maximum).
RSDI scores range from 0 to 120. Subscores are averaged to calculate a total score. Higher score indicates increased impact of sinus disease.
The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 8, 24 and 48 weeks for subjects randomized to BSD versus medical management.
Lower score indicates greater improvement (decreased impact of sinus disease).
Measured: 8, 24, and 48 Weeks
Medication Usage at 24 and 48 Weeks
Comparison of medication usage at 24 and 48 weeks (days oral antibiotics, oral steroids, topical intranasal steroid sprays, and 'atypical' topical steroids (drops or respules)) for subjects randomized to BSD versus medical management.
Measured: 24 Weeks and 48 Weeks
Unscheduled Medical Care Visits Due to Sinusitis
Comparison of unscheduled medical care visits due to sinusitis at 24 and 48 weeks for subjects randomized to BSD versus medical management.
Measured: 24 Weeks and 48 Weeks
Sinus Infections and Sinus Severity - Part 1
Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management.
Measured: 24 Weeks and 48 Weeks
Sinus Infections and Sinus Severity - Part 2
Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management.
Measured: 24 Weeks
Frequency of Second Procedure
Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure.
Measured: Up to 24 weeks
Return to Normal Activity
Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study start1 Oct 2012
- Primary completion1 Oct 2015
- Study completion1 Apr 2016
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.
- Other trials for Recurrent Acute RhinosinusitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Ashley Sikand, MD, Principal investigator, Ear Nose and Throat Consultants of NevadaFord Albritton, MD, Principal investigator, Texas Institute for Sinus & Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714687
- Sponsor's protocol ID
- CPR005030
- Acronym
- CABERNET
- Status last verified
- Jul 2024
- First submitted
- 24 Oct 2012
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Publication planned in the future
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)
- ClinicalTrials.gov ID
- NCT01714687
- Acronym / sponsor ID
- CABERNET / CPR005030
- Conditions
- Recurrent Acute Rhinosinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Posted 11 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| balloon sinus dilation | Active comparator | Device: balloon sinus dilation, Other: medical therapyBalloon sinus dilation will be conducted in-office under local anesthesia. |
| medical therapy | Active comparator | Other: medical therapyMedical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 19 years of age or greater
- diagnosis of recurrent acute rhinosinusitis
- suitable candidate for office-based procedure
- willing and able to read and sign informed consent and remain compliant with protocol and study procedures
- able to read and understand English
Key exclusion criteria (7 listed)
- diagnosis of chronic rhinosinusitis
- prior sinus surgery
- physician determined need for ancillary procedures
- known immune deficiency, ciliary dysfunction and/or autoimmune disease
- clinically significant illness that may interfere with evaluation of the study
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 |
|---|---|---|
| balloon sinus dilationAlso: balloon sinuplasty | Device | balloon sinus dilation |
| medical therapyAlso: medical management | Other | balloon sinus dilation, medical therapy |
Primary outcome
CSS Total Score Change From Baseline to 24 Week Visit
Time frame: 24 Week Visit
The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include "0 Weeks" (minimum), "1-2 Weeks", "3-4 Weeks", "5-6 Weeks", and "7-8 Weeks" (maximum). The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes. The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only. Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score). Higher score indicates greater improvement.
8 secondary outcomes
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks
Time frame: 8, 16, 24, 32, 40, and 48 Weeks
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks
Time frame: 8, 24, and 48 Weeks
Medication Usage at 24 and 48 Weeks
Time frame: 24 Weeks and 48 Weeks
Unscheduled Medical Care Visits Due to Sinusitis
Time frame: 24 Weeks and 48 Weeks
Sinus Infections and Sinus Severity - Part 1
Time frame: 24 Weeks and 48 Weeks
Sinus Infections and Sinus Severity - Part 2
Time frame: 24 Weeks
Frequency of Second Procedure
Time frame: Up to 24 weeks
Return to Normal Activity
Time frame: 2 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Publication planned in the future
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.
Ashley Sikand, MD principal investigator
Ear Nose and Throat Consultants of Nevada
Ford Albritton, MD principal investigator
Texas Institute for Sinus & Respiratory Disease
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon sinus dilation and medical therapy in people with Recurrent Acute Rhinosinusitis, run by Integra LifeSciences Corporation at 5 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 5 inclusion and 7 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 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2019). 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?
CSS Total Score Change From Baseline to 24 Week Visit (time frame: 24 Week Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2024.