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

Chronic Rhinosinusitis Clinical Trial

— CHEC  

Official title:

Canadian Health Economics, Health Outcome, and Effectiveness Comparison of Treatment of the Frontal Sinus Ostium and Recess and Other Sinuses With Functional Endoscopic Sinus Surgery (FESS) or Balloon Sinuplasty in Patients With Chronic Sinusitis (CRS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01455948
• Other study ID #: JJMC-001
• Status: Terminated
• Phase: Phase 4
• First received: October 11, 2011
• Last updated: September 1, 2015
• Start date: February 2012
• Est. completion date: November 2012

Study information

• Verified date: September 2015
• Source: Johnson & Johnson Medical Companies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

Intervention

Device:
• Relieva Balloon Sinuplasty™ System
Catheter-based devices used to dilate blocked paranasal sinus ostia (openings).

Procedure:
• Functional 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.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	St. Joseph's Health Centre	London	Ontario
Canada	Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Joseph's Health Centre	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto East General	Toronto	Ontario
Canada	Trillium Health Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Medical Companies	Acclarent

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.		6 months	No
Secondary	Health outcome of patients in the two treatment groups.	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.	6 months	No
Secondary	Effectiveness of the two treatment groups in relieving symptomology of CRS.	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.	6 months	No