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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

October 11, 2011
November 13, 2012
February 2012
February 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01455948 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Chronic Rhinosinusitis
  • 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.
  • Active Comparator: Balloon Sinuplasty™ System
    Intervention: Device: Relieva Balloon Sinuplasty™ System
  • Active Comparator: Functional Endoscopic Sinus Surgery
    Intervention: Procedure: Functional Endoscopic Sinus Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
December 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01455948
JJMC-001
No
Johnson & Johnson Medical Companies
Johnson & Johnson Medical Companies
Acclarent
Principal Investigator: Ian Witterick, MD, MSc Mount Sinai Hospital, Toronto, Ontario, Canada
Johnson & Johnson Medical Companies
November 2012

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