Status:
TERMINATED
Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Acclarent
Conditions:
Chronic Rhinosinusitis
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01455948
Start Date
February 1 2012
End Date
November 1 2012
Last Update
July 11 2024
Active Locations (8)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
2
St. Joseph's Health Centre
London, Ontario, Canada, N6A 4V2
3
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
4
Trillium Health Centre
Toronto, Ontario, Canada, L5C 4E9