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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01455948
Recruitment Status : Terminated
First Posted : October 20, 2011
Last Update Posted : September 2, 2015
Sponsor:
Collaborator:
Acclarent
Information provided by (Responsible Party):
Johnson & Johnson Medical Companies

Tracking Information
First Submitted Date  ICMJE October 11, 2011
First Posted Date  ICMJE October 20, 2011
Last Update Posted Date September 2, 2015
Study Start Date  ICMJE February 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2011)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Rhinosinusitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Balloon Sinuplasty™ System
    Intervention: Device: Relieva Balloon Sinuplasty™ System
  • Active Comparator: Functional Endoscopic Sinus Surgery
    Intervention: Procedure: Functional Endoscopic Sinus Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 1, 2015)
25
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2011)
200
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01455948
Other Study ID Numbers  ICMJE JJMC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Medical Companies
Study Sponsor  ICMJE Johnson & Johnson Medical Companies
Collaborators  ICMJE Acclarent
Investigators  ICMJE
Principal Investigator: Ian Witterick, MD, MSc Mount Sinai Hospital, Toronto, Ontario, Canada
PRS Account Johnson & Johnson Medical Companies
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP