Ethmoid SinusitisEarly Phase 1SLSNCT02297243
Sinopsys Lacrimal Stent Indicated for Sinus Irrigation
A Early Phase 1 study testing Sinopsys Lacrimal Stent in people with Ethmoid Sinusitis, run by Sinopsys Surgical at 3 sites in United States.
Trial summary
The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Ethmoid Sinusitis
- What is being tested?
- Sinopsys Lacrimal Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2015to Feb 2016
- Phase
- Early Phase 1
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Investigator has determined that the potential study subject has moderate to severe chronic rhinosinusitis with ethmoid involvement and has followed at least twelve (12) weeks of appropriate medical therapy prior to enrollment
- Age ≥ 22 years
- The potential study subject meets the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) criteria for chronic rhinosinusitis 12 weeks or longer of two or more of the following signs and symptoms:
- Mucopurulent drainage (anterior, posterior, or both)
- Nasal obstruction (congestion)
- Facial pain-pressure-fullness, or
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- Decreased sense of smell
- AND inflammation is documented by one or more of the following findings:
- Purulent (not clear) mucus or edema in the middle meatus or ethmoid region
- Polyps in nasal cavity or the middle meatus, and/or
- Radiographic imaging showing inflammation of the paranasal sinuses
- SNOT-20 total score ≥ 41
- CT scan (coronal view) confirms inflammation / involvement of the ethmoid sinuses
- CT scan (coronal view) confirms depth of olfactory fossa is Keros classification 1 or 2.
Who cannot join
- Sinus opacification score of ≤ 8 or ≥ 18 measured using the CT derived Lund -- Mackay scoring system
- Isolated sinus disease evident on CT scan that would be unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid or frontal disease)
- Severe polyposis defined as Grade III or Grade IV polyposis using the adapted scale from Meltzer, 2006.
- Prior ocular and/or sinus surgery for CRS
- CT scan (coronal view) shows depth of olfactory fossa is Keros classification 3.
- Prior surgical history, physical exam, nasal endoscopy and/or imaging studies suggest significant distortion of the craniofacial anatomy thus prohibiting adequate placement of the SLS
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- Presence of a sinonasal encepholocele as determined by CT scan
- Presence of active HEENT infection including acute dacryocystitis
- Febrile illness within 2 weeks and/or active pus from nose
- Any sign of active ophthalmic disease, infection, or inflammation including the presence of severe ocular surface inflammatory disease or signs and symptoms of "dry eye disease" as determined by physical exam which could be exacerbated by the presence of the device
- Current use of topical medications for the eye to treat an active ophthalmic disease
- HbA1c level of ≥ 7.5% at the time of screening, current chemotherapy, or other immune compromised conditions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Front Range ENT
Greeley, Colorado, 80634
Advanced ENT and Allergy
Louisville, Kentucky, 40207
Stanford University
Stanford, California, 94305
About this study
Official title: The Sinopsys Lacrimal Stent Indicated for Sinus Irrigation Via Transcaruncular Ethmoid Sinus Access in Patients With Moderate to Severe Chronic Rhinosinusitis With Ethmoid Sinus Involvement
The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.
Read the detailed description
For purposes of this clinical study, the Sinopsys Lacrimal Stent is intended to provide a means of administering saline sinus irrigation via a transcaruncular-ethmoid sinus access in patients with moderate to severe chronic rhinosinusitis with ethmoid involvement. The purpose of the administration of saline irrigation is to reduce the intensity of symptoms of chronic rhinosinusitis in this patient population.
- Conditions
- Ethmoid Sinusitis
- Being tested
- Sinopsys Lacrimal Stent
- Medical subject headings
- Ethmoid Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinopsys Lacrimal StentDevice
Also called SLS
The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.
| Study group | Role | What they receive |
|---|---|---|
| Sinopsys Lacrimal Stent | Experimental | The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access. Receives: Device: Sinopsys Lacrimal Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNOT - 20
Chronic Rhinosinusitis symptoms as measured by SNOT-20 scores from baseline to 18 weeks follow-up (1, 4, 8, 12, and 18)
Measured: 18 Weeks
Patency will be confirmed post procedure with passive flow through the SLS lumen by instilling 2-4 drops of sterile saline into the stented medial fornix and observing drainage.
Patients will be trained for self-administration of saline irrigation prior to the discharge home. Subjects will be instructed how to observe for stent patency and to report problems with flow to the Investigator.
Measured: 18 Weeks
Safety: Incidence and occurrence of anticipated and unanticipated adverse events
Assessment of the incidence and occurrence of anticipated and unanticipated adverse events reported during the 18 weeks of the clinical study.
Measured: 18 Weeks
Secondary outcomes (2)
Lund-MacKay CT Scores
Comparison of baseline and 12 weeks
Measured: 12 Weeks
Lund-Kennedy Nasal Endoscopy Scores
Comparison of baseline and 12 weeks
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ethmoid 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinopsys Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teena Augustino, Study director, Sinopsys Surgical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297243
- Sponsor's protocol ID
- SLS-US-02
- Acronym
- SLS
- Status last verified
- Feb 2016
- First submitted
- 14 Nov 2014
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sinopsys Lacrimal Stent Indicated for Sinus Irrigation Via Transcaruncular Ethmoid Sinus Access in Patients With Moderate to Severe Chronic Rhinosinusitis With Ethmoid Sinus Involvement
- ClinicalTrials.gov ID
- NCT02297243
- Acronym / sponsor ID
- SLS / SLS-US-02
- Conditions
- Ethmoid Sinusitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sinopsys SurgicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Nov 2014 (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 purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.
Detailed description
For purposes of this clinical study, the Sinopsys Lacrimal Stent is intended to provide a means of administering saline sinus irrigation via a transcaruncular-ethmoid sinus access in patients with moderate to severe chronic rhinosinusitis with ethmoid involvement. The purpose of the administration of saline irrigation is to reduce the intensity of symptoms of chronic rhinosinusitis in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinopsys Lacrimal Stent | Experimental | Device: Sinopsys Lacrimal StentThe Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The Investigator has determined that the potential study subject has moderate to severe chronic rhinosinusitis with ethmoid involvement and has followed at least twelve (12) weeks of appropriate medical therapy prior to enrollment
- Age ≥ 22 years
- The potential study subject meets the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) criteria for chronic rhinosinusitis 12 weeks or longer of two or more of the following signs and symptoms:
- SNOT-20 total score ≥ 41
- CT scan (coronal view) confirms inflammation / involvement of the ethmoid sinuses
Key exclusion criteria (12 listed)
- Sinus opacification score of ≤ 8 or ≥ 18 measured using the CT derived Lund -- Mackay scoring system
- Isolated sinus disease evident on CT scan that would be unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid or frontal disease)
- Severe polyposis defined as Grade III or Grade IV polyposis using the adapted scale from Meltzer, 2006.
- Prior ocular and/or sinus surgery for CRS
- CT scan (coronal view) shows depth of olfactory fossa is Keros classification 3.
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 |
|---|---|---|
| Sinopsys Lacrimal StentAlso: SLSThe Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access. | Device | Sinopsys Lacrimal Stent |
Primary outcome
SNOT - 20
Time frame: 18 Weeks
Chronic Rhinosinusitis symptoms as measured by SNOT-20 scores from baseline to 18 weeks follow-up (1, 4, 8, 12, and 18)
Patency will be confirmed post procedure with passive flow through the SLS lumen by instilling 2-4 drops of sterile saline into the stented medial fornix and observing drainage.
Time frame: 18 Weeks
Patients will be trained for self-administration of saline irrigation prior to the discharge home. Subjects will be instructed how to observe for stent patency and to report problems with flow to the Investigator.
Safety: Incidence and occurrence of anticipated and unanticipated adverse events
Time frame: 18 Weeks
Assessment of the incidence and occurrence of anticipated and unanticipated adverse events reported during the 18 weeks of the clinical study.
2 secondary outcomes
Lund-MacKay CT Scores
Time frame: 12 Weeks
Lund-Kennedy Nasal Endoscopy Scores
Time frame: 12 Weeks
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 12 Feb 2016.
Related trials for Ethmoid Sinusitis
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.
Teena Augustino study director
Sinopsys Surgical Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sinopsys Lacrimal Stent in people with Ethmoid Sinusitis, run by Sinopsys Surgical 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 14 inclusion and 12 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 Feb 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
SNOT - 20 (time frame: 18 Weeks). The study lists 3 primary outcomes in all. 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 Feb 2016.