N/A
Completed N=59
Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)
Recurrent Acute Rhinosinusitis
Source: ClinicalTrials.gov NCT01714687 ↗
Enrolled (actual)
59
Serious AEs
1.7%
Results posted
Mar 2019
Primary outcomePrimary: CSS Total Score Change From Baseline to 24 Week Visit — 37.3; 21.8 scores on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CSS Total Score Change From Baseline to 24 Week Visit |
37.3; 21.8 | — |
| SECONDARY CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks |
3.9; -7.5; 39.6; 24.1; 46.3; 30.1 | — |
| SECONDARY RSDI Total and Sub-score Changes From Baseline Over 48 Weeks |
-1.0; 2.5; -32.9; -17.9; -35.6; -18.7 | — |
| SECONDARY Medication Usage at 24 and 48 Weeks |
0.7; 2.9; 0.5; 2.0; 0.0; 0.0 | — |
| SECONDARY Unscheduled Medical Care Visits Due to Sinusitis |
0.2; 0.9; 0.2; 0.2 | — |
| SECONDARY Sinus Infections and Sinus Severity - Part 1 |
0.2; 0.9; 0.2; 0.4 | — |
| SECONDARY Sinus Infections and Sinus Severity - Part 2 |
25; 16; 1; 10; 0; 1 | — |
| SECONDARY Frequency of Second Procedure |
18 | — |
| SECONDARY Return to Normal Activity |
1.8; 1.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01714687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.