SinusitisORIOS 2NCT01107379
Optimization and Refinement of Technique in In-Office Sinus Dilation 2
An observational study of Sinusitis, run by Integra LifeSciences Corporation at 3 sites in United States.
Trial summary
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- Relieva Balloon Sinuplasty System
- Type of treatment
- Medical device
- How many people
- 203 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2010to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with diagnosis of CRS and planned endoscopic sinus surgery.
Who may be able to join
- Male/Female, 18 year or older
- Diagnosis of Chronic Rhinosinusitis
- Planned Endoscopic Sinus surgery
Who cannot join
- 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.)
Show all 9Show fewer
- Pregnant or lactating female
- Inability to tolerate an awake procedure
- Participation in another investigational clinical study involving treatment for chronic rhinosinusitis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Birmingham, Alabama
Study site
Dublin, Ohio
Study site
Las Vegas, Nevada
About this study
Official title: Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
- Conditions
- Sinusitis
- Being tested
- Relieva Balloon Sinuplasty System
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relieva Balloon Sinuplasty SystemDevice
Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis
| Study group | Role | What they receive |
|---|---|---|
| Balloon catheter device | Dilation of sinuses using Relieva Balloon Sinuplasty System Receives: Device: Relieva Balloon Sinuplasty System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intra-patient Change in SNOT-20 Score
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.
Measured: Baseline and 24 weeks
Mean Intra-patient Change in Lund-Mackay CT Scan Score
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.
Measured: Baseline and 24 weeks
Secondary outcomes (4)
Procedure Tolerability
Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.
Measured: Day 0 (Day of Procedure)
Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary
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
Measured: Day 0 (Day of Procedure)
Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.
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.
Measured: Day 0 (Day of Procedure)
Mean Number of Days to Return to Normal Activities
Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Michael Sillers, MD, Principal investigator, Alabama Alabama Nasal and Sinus Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107379
- Sponsor's protocol ID
- CPR005010
- Acronym
- ORIOS 2
- Status last verified
- Jul 2024
- First submitted
- 12 Apr 2010
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Karanfilov B, Silvers S, Pasha R, Sikand A, Shikani A, Sillers M; ORIOS2 Study Investigators. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013 May;3(5):404-11. doi: 10.1002/alr.21112. Epub 2012 Nov 7.
PubMed 23136057
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
- ClinicalTrials.gov ID
- NCT01107379
- Acronym / sponsor ID
- ORIOS 2 / CPR005010
- Conditions
- Sinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Posted 18 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balloon catheter device | – | Device: Relieva Balloon Sinuplasty SystemDilation of sinuses using Relieva Balloon Sinuplasty System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with diagnosis of CRS and planned endoscopic sinus surgery.
Key inclusion criteria (3 listed)
- Male/Female, 18 year or older
- Diagnosis of Chronic Rhinosinusitis
- Planned Endoscopic Sinus surgery
Key exclusion criteria (9 listed)
- Cystic Fibrosis
- Severe Polyposis
- Sinonasal tumors
- History of facial trauma precluding access to sinus ostium
- Ciliary Disfunction
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 SystemSinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis | Device | Balloon catheter device |
Primary outcome
Mean Intra-patient Change in SNOT-20 Score
Time frame: Baseline and 24 weeks
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.
Mean Intra-patient Change in Lund-Mackay CT Scan Score
Time frame: Baseline and 24 weeks
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.
4 secondary outcomes
Procedure Tolerability
Time frame: Day 0 (Day of Procedure)
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)
Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.
Time frame: Day 0 (Day of Procedure)
Mean Number of Days to Return to Normal Activities
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23136057Karanfilov B, Silvers S, Pasha R, Sikand A, Shikani A, Sillers M; ORIOS2 Study Investigators. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013 May;3(5):404-11. doi: 10.1002/alr.21112. Epub 2012 Nov 7.
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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.
Michael Sillers, MD principal investigator
Alabama Alabama Nasal and Sinus Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis, run by Integra LifeSciences Corporation at 3 sites in United States.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 18 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Intra-patient Change in SNOT-20 Score (time frame: Baseline and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01107379, which also lists 1 linked publication.
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 6 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.