Chronic RhinosinusitisCHECNCT01455948
Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis
A study testing Relieva Balloon Sinuplasty™ System and Functional Endoscopic Sinus Surgery in people with Chronic Rhinosinusitis, run by Integra LifeSciences Corporation at 8 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Relieva Balloon Sinuplasty™ System and Functional Endoscopic Sinus Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesCanada
- Study dates
- Feb 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous sinonasal surgery
- Pregnant
- Cystic Fibrosis
- Diagnosed immotile cilia syndrome
- Samter's Triad
- Diagnosed immunodeficiency syndrome
Show all 15Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
St. Joseph's Health Centre
London, Ontario, N6A 4V2
Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9
Trillium Health Centre
Toronto, Ontario, L5C 4E9
Toronto East General
Toronto, Ontario, M4C 3E7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5
About this study
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)
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.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Relieva Balloon Sinuplasty™ System, Functional Endoscopic Sinus Surgery
- Keywords
- sinusitis, chronic, Functional endoscopic sinus surgery, balloon sinuplasty
- Medical subject headings
- Sinusitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relieva Balloon Sinuplasty™ SystemDevice
Catheter-based devices used to dilate blocked paranasal sinus ostia (openings).
Functional Endoscopic Sinus SurgeryProcedure or 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 group | Role | What they receive |
|---|---|---|
| Balloon Sinuplasty™ System | Active comparator | Not described Receives: Device: Relieva Balloon Sinuplasty™ System |
| Functional Endoscopic Sinus Surgery | Active comparator | Not described Receives: Procedure: Functional Endoscopic Sinus Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.
Measured: 6 months
Secondary outcomes (2)
Health outcome of patients in the two treatment groups.
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.
Measured: 6 months
Effectiveness of the two treatment groups in relieving symptomology of CRS.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Ian Witterick, MD, MSc, Principal investigator, Mount Sinai Hospital, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455948
- Sponsor's protocol ID
- JJMC-001
- Acronym
- CHEC
- Status last verified
- Jul 2024
- First submitted
- 11 Oct 2011
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01455948
- Acronym / sponsor ID
- CHEC / JJMC-001
- Conditions
- Chronic Rhinosinusitis
- Keywords
- sinusitis, chronic, Functional endoscopic sinus surgery, balloon sinuplasty
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Sinuplasty™ System | Active comparator | Device: Relieva Balloon Sinuplasty™ System |
| Functional Endoscopic Sinus Surgery | Active comparator | Procedure: Functional Endoscopic Sinus Surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- Previous sinonasal surgery
- Pregnant
- Cystic Fibrosis
- Diagnosed immotile cilia syndrome
- Samter's Triad
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relieva Balloon Sinuplasty™ SystemCatheter-based devices used to dilate blocked paranasal sinus ostia (openings). | Device | Balloon Sinuplasty™ System |
| Functional Endoscopic Sinus SurgerySpecialized probes are used to cannulate closed ostia (openings), and small forceps are used to resect periostial bone and tissue to enlarge the sinus ostia. | Procedure or surgery | Functional Endoscopic Sinus Surgery |
Primary outcome
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
2 secondary outcomes
Health outcome of patients in the two treatment groups.
Time frame: 6 months
Effectiveness of the two treatment groups in relieving symptomology of CRS.
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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Enrolling by invitationObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Witterick, MD, MSc principal investigator
Mount Sinai Hospital, Toronto, Ontario, Canada
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relieva Balloon Sinuplasty™ System and Functional Endoscopic Sinus Surgery in people with Chronic Rhinosinusitis, run by Integra LifeSciences Corporation at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.