SinusitisNCT02463279
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
A study testing Sinusys Dilation System in people with Sinusitis, run by SinuSys Corporation at 3 sites in United States.
Trial summary
The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis. 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
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2015to Mar 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CRS
- Subject in in need of frontal recess and/or sphenoid sinus dilation
Who cannot join
- Pregnant or breastfeeding females
- Previous treatment site intervention
- Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
St. Elizabeth Medical Center
Brighton, Massachusetts, 02135
Colorado ENT
Denver, Colorado, 80210
Upland ENT
Upland, California, 91786
About this study
The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.
Read the detailed description
A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).
- 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
Dilation of frontal recess and/or sphenoid sinus ostia
| Study group | Role | What they receive |
|---|---|---|
| SinuSys Dilation System | Experimental | Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty) 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 target site
Patency assessed by investigator via endoscopic evaluation of the target site
Measured: Patency immediately post device expansion and removal
Secondary outcomes (2)
Patency of treated target site
Patency assessed by investigator via endoscopic evaluation of the target site
Measured: 1 month and 3 months
Reports of sinus related adverse events during the 3 months follow-up period
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- SinuSys Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome Hester, MD, Study director, SinuSys Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463279
- Sponsor's protocol ID
- SNS-006
- Status last verified
- Dec 2016
- First submitted
- 2 Jun 2015
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
- ClinicalTrials.gov ID
- NCT02463279
- Acronym / sponsor ID
- SNS-006
- Conditions
- Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SinuSys CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Jun 2015 (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 goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.
Detailed description
A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).
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 SystemOpening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of CRS
- Subject in in need of frontal recess and/or sphenoid sinus dilation
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding females
- Previous treatment site intervention
- Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation
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 SystemDilation of frontal recess and/or sphenoid sinus ostia | Device | SinuSys Dilation System |
Primary outcome
Patency of treated target site
Time frame: Patency immediately post device expansion and removal
Patency assessed by investigator via endoscopic evaluation of the target site
2 secondary outcomes
Patency of treated target site
Time frame: 1 month and 3 months
Reports of sinus related adverse events during the 3 months follow-up period
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
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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.
Jerome Hester, MD study director
SinuSys Chief Medical Officer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinusys Dilation System in people with Sinusitis, run by SinuSys 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 2 inclusion and 3 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 13 Dec 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 target site (time frame: Patency immediately post device expansion and removal). 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 13 Dec 2016.