SinusitisPhase 1NCT01623050
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
A Phase 1 study testing SinuSys Dilation System in people with Sinusitis, run by SinuSys Corporation at 5 sites in 3 countries.
Trial summary
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- SinuSys Dilation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Apr 2012to Sep 2014
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Diagnosis of chronic maxillary sinusitis
Who cannot join
- Previous antrostomy
- Sinonasal tumours
- Cystic fibrosis
- History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus
- Pregnant or breastfeeding females
- Currently participating in another drug or device study
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
St. Elizabeth Medical Center
Boston, Massachusetts, 02135
Palo Alto Medical Foundation
Palo Alto, California, 94301
Valley ENT
Tucson, Arizona, 85745
Canada1 site
St. Paul's Hospital, ENT Department
Vancouver, British Columbia, BC V6Z 1Y6
About this study
Official title: SinuSys Patency of Maxillary Sinus Ostia Study
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
Read the detailed description
A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis
- Conditions
- Sinusitis
- Being tested
- SinuSys Dilation System
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinuSys Dilation SystemDevice
Sinuplasty
| Study group | Role | What they receive |
|---|---|---|
| SinuSys Dilation System | Experimental | Maxillary Sinus Dilation Receives: Device: SinuSys Dilation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency of Treated Area
Measured: Immediately post procedure
Secondary outcomes (4)
Patency of Treated Area
Maxillary Sinus Ostia Patency of 33 patients analyzed.
Measured: 3 months
Number of Participants With Device-related Adverse Events as a Measure of Safety
Measured: 3 months
Patency of Treated Area
Maxillary Sinus Ostia Patency of 29 patients analyzed.
Measured: 6 months
Patency of Treated Area
Maxillary Sinus Ostia of 27 patients analyzed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completionSep 2014
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 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SinuSys Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Catalano, MD, Principal investigator, St Elizabeth Medical CenterAmin Javer, MD, Principal investigator, St. Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623050
- Sponsor's protocol ID
- SNS-005
- Status last verified
- Oct 2014
- First submitted
- 13 Jun 2012
- Last updated
- 5 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SinuSys Patency of Maxillary Sinus Ostia Study
- ClinicalTrials.gov ID
- NCT01623050
- Acronym / sponsor ID
- SNS-005
- Conditions
- Sinusitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SinuSys CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Posted 1 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
Detailed description
A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SinuSys Dilation System | Experimental | Device: SinuSys Dilation SystemMaxillary Sinus Dilation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Diagnosis of chronic maxillary sinusitis
Key exclusion criteria (6 listed)
- Previous antrostomy
- Sinonasal tumours
- Cystic fibrosis
- History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus
- Pregnant or breastfeeding females
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 |
|---|---|---|
| SinuSys Dilation SystemSinuplasty | Device | SinuSys Dilation System |
Primary outcome
Patency of Treated Area
Time frame: Immediately post procedure
4 secondary outcomes
Patency of Treated Area
Time frame: 3 months
Number of Participants With Device-related Adverse Events as a Measure of Safety
Time frame: 3 months
Patency of Treated Area
Time frame: 6 months
Patency of Treated Area
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Catalano, MD principal investigator
St Elizabeth Medical Center
Amin Javer, MD principal investigator
St. Paul's Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SinuSys Dilation System in people with Sinusitis, run by SinuSys Corporation at 5 sites in 3 countries.
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 1 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 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada, United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 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?
Patency of Treated Area (time frame: Immediately post procedure). 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 5 Nov 2014; AzTrials last refreshed its copy on 6 Nov 2026.