- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01107379
Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States
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Nevada
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Las Vegas, Nevada, United States
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Ohio
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Dublin, Ohio, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male/Female, 18 year or older
- Diagnosis of Chronic Rhinosinusitis
- Planned Endoscopic Sinus surgery
Exclusion Criteria:
- Cystic Fibrosis
- Severe Polyposis
- Sinonasal tumors
- History of facial trauma precluding access to sinus ostium
- Ciliary Disfunction
- Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.)
- Pregnant or lactating female
- Inability to tolerate an awake procedure
- Participation in another investigational clinical study involving treatment for chronic rhinosinusitis
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Balloon catheter device
Dilation of sinuses using Relieva Balloon Sinuplasty System
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Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Intra-patient Change in SNOT-20 Score
Time Frame: Baseline and 24 weeks
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Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5. |
Baseline and 24 weeks
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Mean Intra-patient Change in Lund-Mackay CT Scan Score
Time Frame: Baseline and 24 weeks
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Change in Lund-Mackay CT score for paired baseline and 24 week data. The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden. |
Baseline and 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedure Tolerability
Time Frame: Day 0 (Day of Procedure)
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Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.
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Day 0 (Day of Procedure)
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Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary
Time Frame: Day 0 (Day of Procedure)
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Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary
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Day 0 (Day of Procedure)
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Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.
Time Frame: Day 0 (Day of Procedure)
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Procedure success is defined as achievement of the goal of the treatment.
The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.
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Day 0 (Day of Procedure)
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Mean Number of Days to Return to Normal Activities
Time Frame: 2 weeks
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Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living
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2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Sillers, MD, Alabama Alabama Nasal and Sinus Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPR005010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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