Chronic Rhinosinusitis
Conditions
Keywords
sinusitis, chronic, Functional endoscopic sinus surgery, balloon sinuplasty
Brief summary
The economic, patient related outcome, and effectiveness of balloon sinuplasty in the treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare environment is not known at this time. This study will evaluate the impact of balloon sinuplasty and traditional FESS treatment on CRS patients.
Interventions
DEVICERelieva Balloon Sinuplasty™ System
Catheter-based devices used to dilate blocked paranasal sinus ostia (openings).
PROCEDUREFunctional Endoscopic Sinus Surgery
Specialized probes are used to cannulate closed ostia (openings), and small forceps are used to resect periostial bone and tissue to enlarge the sinus ostia.
Sponsors
Integra LifeSciences Corporation
Acclarent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of unilateral or bilateral Chronic Rhinosinusitis based on the European Position Paper on Rhinosinusitis and Nasal Polyps (2) with at least frontal and maxillary sinus involvement * Documented failed medical treatment of CRS * Eighteen (18) to sixty-five (65) years of age * Employed in full time position or equivalent * Planned FESS for treatment of CRS * Must have an American Society of Anesthesiologists physical status of P3 classification or less * Able to provide informed consent by signing the informed consent document at the screening visit prior to any study activities * Able to read and understand English
Exclusion criteria
* Previous sinonasal surgery * Pregnant * Cystic Fibrosis * Diagnosed immotile cilia syndrome * Samter's Triad * Diagnosed immunodeficiency syndrome * Diagnosed fungal sinusitis * Concurrent septoplasty or turbinate surgery * Diagnosed recurrent acute sinusitis * Current smoker * Presence of grade 2 or greater nasal polyps * Sinonasal tumors or obstructive lesions * History of substance or alcohol abuse within the past 12 months * Investigator's opinion that the subject should not be in the study such as any conditions that could compromise the wellbeing of the patient or integrity of the study or prevent the patient from meeting or performing study requirements * Participation in a research study 30 days prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty. | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health outcome of patients in the two treatment groups. | 6 months | Health outcomes will be determined by the completion of the EQ-5D questionnaire in both treatment groups at various timepoint. The EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. |
| Effectiveness of the two treatment groups in relieving symptomology of CRS. | 6 months | Effectiveness of the two treatment groups in relieving symptomology of CRS will be determined by the completion of the Sino-nasal Outcome Test - 20 (SNOT-20) questionnaire in both treatment groups at various timepoint. The SNOT-20 questionnaire is a validated instrument for the measurement of disease specific health status and quality of life in patients with chronic rhinosinusitis. |
Countries
Canada
Outcome results
None listed