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

September 1, 2015 updated by: Johnson & Johnson Medical Companies

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Centre
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital - Civic Campus
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General
      • Toronto, Ontario, Canada, M6R 1B5
        • St. Joseph's Health Centre
      • Toronto, Ontario, Canada, L5C 4E9
        • Trillium Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Balloon Sinuplasty™ System
Device: Relieva Balloon Sinuplasty™ System
Catheter-based devices used to dilate blocked paranasal sinus ostia (openings).
Active Comparator: Functional Endoscopic Sinus Surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health outcome of patients in the two treatment groups.
Time Frame: 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.
6 months
Effectiveness of the two treatment groups in relieving symptomology of CRS.
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Medical Companies

Collaborators

Acclarent

Investigators

  • Principal Investigator: Ian Witterick, MD, MSc, Mount Sinai Hospital, Toronto, Ontario, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

October 19, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJMC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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