N/A
N=198
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT01685229 ↗Enrolled (actual)
198
Serious AEs
3.0%
Results posted
May 2019
Primary outcome: Primary: Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline — 41.9; 27.0 Scores on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Balloon sinus dilation (Device); Medical Management (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline |
41.9; 27.0 | — |
| SECONDARY Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline |
28.5; 34.3; 73.3; 60.2; 43.6; 29.9 | — |
| SECONDARY Change in RSDI |
47.9; 39.5; 13.0; 26.0; -34.7; -14.7 | — |
| SECONDARY Change in SNOT-20 |
2.5; 2.4; 0.9; 1.5; -1.6; -0.9 | — |
| SECONDARY Change in Disease-specific Medication Usage |
28.1; 22.8; 5.7; 6.6; -22.2; -16.7 | — |
| SECONDARY Missed Days Work/School |
3.0; 1.4; 0.2; 0.0; 0.4; 0.1 | — |
| SECONDARY Number of Sinus-related Medical Care Visits |
2.0; 1.2; 0.1; 0.1; 0.1; 0.1 | — |
| SECONDARY Number of Sinus Infections |
0.3; 0.3; 0.5; 0.6 | — |
| SECONDARY Number of Subjects Requiring Revision for Subjects Electing BSD |
3; 0 | — |
| SECONDARY Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure |
12 | — |
| SECONDARY Post-operative Return to Normal Activity (RTNA) |
3.6; 2.8; 5.9 | — |
Summary
This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
Eligibility Criteria
Inclusion Criteria
- Males and females aged 19 or greater
- Diagnosis of Chronic Rhinosinusitis (CRS)
- Failure of appropriate medical management
- Radiographic evidence of inflammation of the paranasal sinuses
- Surgical candidate
- Willing and able to read and sign the Informed Consent Form and remain compliant with the protocol and study procedures
- Able to read and understand English
Exclusion Criteria
- Not suitable for balloon dilation for all peripheral sinuses that require treatment
- Clinically significant illness that may interfere with the evaluation of the study
- Patients involved in other clinical studies 30 days prior to study
- Pregnant or lactating females
- Patients unable to adhere to follow-up schedule or protocol requirements
Data sourced from ClinicalTrials.gov (NCT01685229). 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.