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

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ClinicalTrials.gov Identifier: NCT01714687
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Acclarent

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.

Condition or disease Intervention/treatment Phase
Recurrent Acute Rhinosinusitis Device: balloon sinus dilation Other: medical therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)
Actual Study Start Date : October 1, 2012
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : April 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Active Comparator: balloon sinus dilation
Balloon sinus dilation will be conducted in-office under local anesthesia.
Device: balloon sinus dilation
Other Name: balloon sinuplasty

Other: medical therapy
Other Name: medical management

Active Comparator: medical therapy
Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment.
Other: medical therapy
Other Name: medical management




Primary Outcome Measures :
  1. Change in disease-specific patient-reported quality of life (QOL) [ Time Frame: 24 weeks post treatment ]

Secondary Outcome Measures :
  1. Change in disease-specific patient-reported quality of life [ Time Frame: 24 and 48 weeks post treatment ]
  2. Change in disease-specific and general health-related quality of life [ Time Frame: 8, 24 and 48 weeks post treatment ]
  3. Change in disease-specific medication usage [ Time Frame: 24 and 48 weeks post treatment ]
  4. Missed days work/school and medical care visits due to sinusitis [ Time Frame: 24 and 48 weeks post treatment ]
  5. Number of sinus infections [ Time Frame: 48 weeks post treatment ]
  6. Number of subjects electing procedure (cross-over) [ Time Frame: 48 weeks post treatment ]
  7. Post-procedure return to normal activity (RTNA) [ Time Frame: 2 weeks post treatment ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714687


Locations
United States, Alabama
Birmingham, Alabama, United States, 35242
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Nevada
Las Vegas, Nevada, United States, 89113
United States, Texas
Dallas, Texas, United States, 75231
McKinney, Texas, United States, 75070
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Ashley Sikand, MD Ear Nose and Throat Consultants of Nevada
Principal Investigator: Ford Albritton, MD Texas Institute for Sinus & Respiratory Disease

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01714687     History of Changes
Other Study ID Numbers: CPR005030
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication planned in the future

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases