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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01714687
Recruitment Status : Completed
First Posted : October 26, 2012
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Acclarent

Tracking Information
First Submitted Date  ICMJE October 24, 2012
First Posted Date  ICMJE October 26, 2012
Results First Submitted Date  ICMJE October 18, 2018
Results First Posted Date  ICMJE March 11, 2019
Last Update Posted Date March 11, 2019
Actual Study Start Date  ICMJE October 1, 2012
Actual Primary Completion Date October 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2012)
Change in disease-specific patient-reported quality of life (QOL) [ Time Frame: 24 weeks post treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Return to Normal Activity [ Time Frame: 2 week ]
    Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2012)
  • Change in disease-specific patient-reported quality of life [ Time Frame: 24 and 48 weeks post treatment ]
  • Change in disease-specific and general health-related quality of life [ Time Frame: 8, 24 and 48 weeks post treatment ]
  • Change in disease-specific medication usage [ Time Frame: 24 and 48 weeks post treatment ]
  • Missed days work/school and medical care visits due to sinusitis [ Time Frame: 24 and 48 weeks post treatment ]
  • Number of sinus infections [ Time Frame: 48 weeks post treatment ]
  • Number of subjects electing procedure (cross-over) [ Time Frame: 48 weeks post treatment ]
  • Post-procedure return to normal activity (RTNA) [ Time Frame: 2 weeks post treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)
Official Title  ICMJE Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Acute Rhinosinusitis
Intervention  ICMJE
  • Device: balloon sinus dilation
    Other Name: balloon sinuplasty
  • Other: medical therapy
    Other Name: medical management
Study Arms  ICMJE
  • Active Comparator: balloon sinus dilation
    Balloon sinus dilation will be conducted in-office under local anesthesia.
    Interventions:
    • Device: balloon sinus dilation
    • Other: medical therapy
  • Active Comparator: medical therapy
    Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment.
    Intervention: Other: medical therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2015)
59
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2012)
400
Actual Study Completion Date  ICMJE April 1, 2016
Actual Primary Completion Date October 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01714687
Other Study ID Numbers  ICMJE CPR005030
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Publication planned in the future
Responsible Party Acclarent
Study Sponsor  ICMJE Acclarent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ashley Sikand, MD Ear Nose and Throat Consultants of Nevada
Principal Investigator: Ford Albritton, MD Texas Institute for Sinus & Respiratory Disease
PRS Account Acclarent
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP