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

This study has been terminated.
Sponsor:
Collaborator:
Acclarent
Information provided by (Responsible Party):
Johnson & Johnson Medical Companies
ClinicalTrials.gov Identifier:
NCT01455948
First received: October 11, 2011
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Chronic Rhinosinusitis
Device: Relieva Balloon Sinuplasty™ System
Procedure: Functional Endoscopic Sinus Surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
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)

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Medical Companies:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health outcome of patients in the two treatment groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455948

Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
St. Joseph's Health Centre
London, Ontario, Canada, N6A 4V2
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Trillium Health Centre
Toronto, Ontario, Canada, L5C 4E9
Toronto East General
Toronto, Ontario, Canada, M4C 3E7
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Johnson & Johnson Medical Companies
Acclarent
Investigators
Principal Investigator: Ian Witterick, MD, MSc Mount Sinai Hospital, Toronto, Ontario, Canada
  More Information

No publications provided

Responsible Party: Johnson & Johnson Medical Companies
ClinicalTrials.gov Identifier: NCT01455948     History of Changes
Other Study ID Numbers: JJMC-001
Study First Received: October 11, 2011
Last Updated: November 13, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Johnson & Johnson Medical Companies:
sinusitis
chronic
Functional endoscopic sinus surgery
balloon sinuplasty

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014