Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis
NCT ID: NCT01455948
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
25 participants
INTERVENTIONAL
2012-02-29
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Balloon Sinuplasty™ System
Relieva Balloon Sinuplasty™ System
Catheter-based devices used to dilate blocked paranasal sinus ostia (openings).
Functional Endoscopic Sinus Surgery
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.
Interventions
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Relieva Balloon Sinuplasty™ System
Catheter-based devices used to dilate blocked paranasal sinus ostia (openings).
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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Acclarent
INDUSTRY
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ian Witterick, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Hospital, Toronto, Ontario, Canada
Locations
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Hamilton General Hospital
Hamilton, Ontario, Canada
St. Joseph's Health Centre
London, Ontario, Canada
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
Trillium Health Centre
Toronto, Ontario, Canada
Toronto East General
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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JJMC-001
Identifier Type: -
Identifier Source: org_study_id
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