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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01714687
First received: October 24, 2012
Last updated: June 29, 2017
Last verified: June 2017
  Purpose
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 Intervention
Recurrent Acute Rhinosinusitis Device: balloon sinus dilation Other: medical therapy

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Acclarent:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 59
Actual Study Start Date: October 1, 2012
Study Completion Date: April 1, 2016
Primary Completion Date: October 1, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01714687     History of Changes
Other Study ID Numbers: CPR005030
Study First Received: October 24, 2012
Last Updated: June 29, 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

ClinicalTrials.gov processed this record on August 18, 2017