Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)
NCT ID: NCT01714687
Last Updated: 2024-07-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2012-10-01
2016-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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balloon sinus dilation
Balloon sinus dilation will be conducted in-office under local anesthesia.
balloon sinus dilation
medical therapy
medical therapy
Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment.
medical therapy
Interventions
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balloon sinus dilation
medical therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Acclarent
INDUSTRY
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ashley Sikand, MD
Role: PRINCIPAL_INVESTIGATOR
Ear Nose and Throat Consultants of Nevada
Ford Albritton, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Institute for Sinus & Respiratory Disease
Locations
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Birmingham, Alabama, United States
Atlanta, Georgia, United States
Las Vegas, Nevada, United States
Dallas, Texas, United States
McKinney, Texas, United States
Countries
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Other Identifiers
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CPR005030
Identifier Type: -
Identifier Source: org_study_id
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