Chronic SinusitisORIOSNCT00939393
Balloon Sinus Dilation In Office or OR
A study testing FESS instruments with or without balloon treatment and Balloon Sinuplasty in people with Chronic Sinusitis, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- FESS instruments with or without balloon treatment and Balloon Sinuplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2008to 1 Jul 2010
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years and greater
- Both male and female patients eligible
- Diagnosis of chronic sinusitis that is not responsive to medical management (> 12 weeks of symptoms and failed at least 3 to 6 weeks of appropriate antibiotic therapy as evidenced by presence of disease on CT scan)
- Planned endoscopic sinus surgery (recommended by investigator, consented to by patient)
Who cannot join
- Cystic fibrosis
- Samter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
- Sinonasal tumors or obstructive lesions
- History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- Ciliary dysfunction
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockside Road Surgery Center
Independence, Ohio, 44131
About this study
Official title: ESS Performed in Operating Room Versus Clinician's Office
Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.
Read the detailed description
In this study, endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with the balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices. Both primary treatment of sinusitis as well as revision of previously treated sinuses will be allowed. Resource absorption will be evaluated for both venues.
- Conditions
- Chronic Sinusitis
- Being tested
- FESS instruments with or without balloon treatment, Balloon Sinuplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FESS instruments with or without balloon treatmentDevice
Intervention with metal instruments with or without balloon treatment
Balloon SinuplastyDevice
Balloon dilatation of sinuses
| Study group | Role | What they receive |
|---|---|---|
| FESS in OR with or without balloons | Active comparator | Functional Endoscopy Sinus Surgery Receives: Device: FESS instruments with or without balloon treatment |
| Balloon sinuplasty in physician office | Active comparator | Balloon Sinuplasty in physician office using Acclarent devices Receives: Device: Balloon Sinuplasty |
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 at 24 Weeks Post-procedure Compared to Baseline
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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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: 24 weeks
Secondary outcomes (9)
Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]
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: 24 weeks
Proportion of Participants Rating Procedure as Tolerable (IO Only)
Participants evaluated the tolerability of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'not tolerated' and '5' represented 'highly tolerable'. Scores of 3 through 5 were consdered tolerable ratings. The endpoint reports the proportion of participants rating the procedure as tolerable.
Measured: Day 0
Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)
Participants evaluated the per-procedural pain of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'no pain' and '5' represented 'intense pain'. Scores of 0 through 2 were considered ratings of no pain or pain of low intensity. The endpoint reports the proportion of participants reporting no pain or pain of low intensity.
Measured: Day 0
Mean Number of Debridements Per Participant (IO Only)
A debridement is a procedure to remove post-surgical crusts, mucus, and fibrin from obstructed nasal and sinus cavities after functional endoscopic sinus surgery. Each physician visit in which a debridement was performed was counted as one debridement.
Measured: 52 weeks
Proportion of Participants With Revisions (IO Only)
After sinus surgery, the patient may require a subsequent sinus procedure (a revision procedure) to address recurrence of disease. These revision procedures are assessed in this outcome measure.
Measured: 52 weeks
Proportion of Participants With Post-operative Sinus Infections
Investigators reported the sinus infections as secondary to chronic rhinosinusitis (CRS) or other pre-existing conditions such as allergies. The rates of these sinus infections are consistent with the disease burden of the subjects and consistent with post procedure symptomatology associated with endoscopic sinus surgery (ESS).
Measured: 52 weeks
Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline
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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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: 1 week
Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline
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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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: 4 weeks
Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline
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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study start1 Apr 2008
- Primary completion1 Jun 2009
- Study completion1 Jul 2010
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.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Howard Levine, MD, Principal investigator, Rockside Road Surgery Center Independence, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939393
- Sponsor's protocol ID
- CPR005002
- Acronym
- ORIOS
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2009
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESS Performed in Operating Room Versus Clinician's Office
- ClinicalTrials.gov ID
- NCT00939393
- Acronym / sponsor ID
- ORIOS / CPR005002
- Conditions
- Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 1 Jun 2009 (actual)
- Study completion
- 1 Jul 2010 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Posted 3 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.
Detailed description
In this study, endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with the balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices. Both primary treatment of sinusitis as well as revision of previously treated sinuses will be allowed. Resource absorption will be evaluated for both venues.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FESS in OR with or without balloons | Active comparator | Device: FESS instruments with or without balloon treatmentFunctional Endoscopy Sinus Surgery |
| Balloon sinuplasty in physician office | Active comparator | Device: Balloon SinuplastyBalloon Sinuplasty in physician office using Acclarent devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and greater
- Both male and female patients eligible
- Diagnosis of chronic sinusitis that is not responsive to medical management (> 12 weeks of symptoms and failed at least 3 to 6 weeks of appropriate antibiotic therapy as evidenced by presence of disease on CT scan)
- Planned endoscopic sinus surgery (recommended by investigator, consented to by patient)
Key exclusion criteria (6 listed)
- Cystic fibrosis
- Samter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
- Sinonasal tumors or obstructive lesions
- History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- Ciliary dysfunction
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 |
|---|---|---|
| FESS instruments with or without balloon treatmentIntervention with metal instruments with or without balloon treatment | Device | FESS in OR with or without balloons |
| Balloon SinuplastyBalloon dilatation of sinuses | Device | Balloon sinuplasty in physician office |
Primary outcome
Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline
Time frame: 24 weeks
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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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.
9 secondary outcomes
Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]
Time frame: 24 weeks
Proportion of Participants Rating Procedure as Tolerable (IO Only)
Time frame: Day 0
Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)
Time frame: Day 0
Mean Number of Debridements Per Participant (IO Only)
Time frame: 52 weeks
Proportion of Participants With Revisions (IO Only)
Time frame: 52 weeks
Proportion of Participants With Post-operative Sinus Infections
Time frame: 52 weeks
Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline
Time frame: 1 week
Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline
Time frame: 4 weeks
Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Sinusitis
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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.
Howard Levine, MD principal investigator
Rockside Road Surgery Center Independence, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FESS instruments with or without balloon treatment and Balloon Sinuplasty in people with Chronic Sinusitis, run by Integra LifeSciences Corporation at 1 site 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 4 inclusion and 6 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 12 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 1 site 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 3 Oct 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 at 24 Weeks Post-procedure Compared to Baseline (time frame: 24 weeks). 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 12 Jul 2024.