Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis

Not Applicable

Terminated

• Conditions: Chronic Rhinosinusitis
• Interventions: Procedure: Functional Endoscopic Sinus Surgery; Device: Relieva Balloon Sinuplasty™ System

• Registration Number: NCT01455948
• Lead Sponsor: Integra LifeSciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Study Start: 2012-02
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional Endoscopic Sinus Surgery	Functional Endoscopic Sinus Surgery	-
Balloon Sinuplasty™ System	Relieva Balloon Sinuplasty™ System	-

Primary Outcome Measures

Name	Time	Method
The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.	6 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Joseph's Health Centre; 🇨🇦 Toronto, Ontario, Canada

Ottawa Hospital - Civic Campus; 🇨🇦 Ottawa, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Trillium Health Centre; 🇨🇦 Toronto, Ontario, Canada

Toronto East General; 🇨🇦 Toronto, Ontario, Canada