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OpenTrials
Completed

NCT Number: NCT01714687

Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (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.

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Key information

Conditions

Recurrent Acute Rhinosinusitis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Balloon Sinus Dilation

Device

Other names: balloon sinuplasty

Medical therapy

Other

Other names: medical management

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. RSDI Total and Sub-score Changes From Baseline Over 48 Weeks

    Time frame: 8, 24, and 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).

  3. Medication Usage at 24 and 48 Weeks

    Time frame: 24 Weeks 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.

  4. Unscheduled Medical Care Visits Due to Sinusitis

    Time frame: 24 Weeks and 48 Weeks

    Comparison of unscheduled medical care visits due to sinusitis at 24 and 48 weeks for subjects randomized to BSD versus medical management.

  5. Sinus Infections and Sinus Severity - Part 1

    Time frame: 24 Weeks and 48 Weeks

    Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management.

  6. Sinus Infections and Sinus Severity - Part 2

    Time frame: 24 Weeks

    Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management.

  7. Frequency of Second Procedure

    Time frame: Up to 24 weeks

    Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure.

  8. Return to Normal Activity

    Time frame: 2 week

    Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Official study title

Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)

Acronym: CABERNET

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Oct 26, 2012
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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