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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Acclarent
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01714687
First received: October 24, 2012
Last updated: March 12, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in disease-specific patient-reported quality of life [ Time Frame: 24 and 48 weeks post treatment ] [ Designated as safety issue: No ]
  • Change in disease-specific and general health-related quality of life [ Time Frame: 8, 24 and 48 weeks post treatment ] [ Designated as safety issue: No ]
  • Change in disease-specific medication usage [ Time Frame: 24 and 48 weeks post treatment ] [ Designated as safety issue: No ]
  • Missed days work/school and medical care visits due to sinusitis [ Time Frame: 24 and 48 weeks post treatment ] [ Designated as safety issue: No ]
  • Number of sinus infections [ Time Frame: 48 weeks post treatment ] [ Designated as safety issue: No ]
  • Number of subjects electing procedure (cross-over) [ Time Frame: 48 weeks post treatment ] [ Designated as safety issue: No ]
  • Post-procedure return to normal activity (RTNA) [ Time Frame: 2 weeks post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 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
Genders Eligible for Study:   Both
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

Contacts
Contact: England lenglan1@its.jnj.com

Locations
United States, Alabama
Alabama Nasal and Sinus Center Recruiting
Birmingham, Alabama, United States, 35242
United States, Georgia
ENT of Georgia Recruiting
Atlanta, Georgia, United States, 30342
United States, Nevada
Ear Nose and Throat Consultants of Nevada Recruiting
Las Vegas, Nevada, United States, 89113
United States, Texas
ENT Associates of Texas Recruiting
McKinney, Texas, United States, 75070
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Ashley Sikand, MD Ear Nose and Throat Consultants of Nevada
Principal Investigator: Michael Sillers, MD Alabama Nasal and Sinus Center
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01714687     History of Changes
Other Study ID Numbers: CPR005030
Study First Received: October 24, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 14, 2014