Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis (CHEC)
Status
Terminated
Conditions
Chronic Rhinosinusitis
Treatments
Procedure: Functional Endoscopic Sinus Surgery
Device: Relieva Balloon Sinuplasty™ System
Details and patient eligibility
About
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.
Enrollment
25 patients
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Health Services Research
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
25 participants in 2 patient groups
Balloon Sinuplasty™ System
Active Comparator group
Treatment:
Device: Relieva Balloon Sinuplasty™ System
Functional Endoscopic Sinus Surgery
Active Comparator group
Treatment:
Procedure: Functional Endoscopic Sinus Surgery
Trial contacts and locations
8
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems