Ethmoid SinusitisNCT03304951
Sinopsys® Lacrimal Stent Indicated for Sinus Irrigation
A study testing Sinopsys® Lacrimal Stent in people with Ethmoid Sinusitis, run by Sinopsys Surgical at 1 site in Czechia.
Trial summary
The primary objective is to evaluate 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
- 8 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2016to Aug 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Investigator has determined that the potential study subject has moderate to severe chronic rhino sinusitis with ethmoid involvement and has failed 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 rhino sinusitis (Rosenfeld, et al, 2007)
- 12 weeks or longer of two or more o f 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 si documents 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 raw score ≥ 41
- Non-Contrast CT scan (coronal view) confirms depth of olfactory fossa is Keros classification 1or 2 (Gauba, Sleh, Dua, Agarwal, Ell, \& Vize, 2006)
- The potential study subject is capable of understanding and executing written informed consent (IC)
Who cannot join
- Sinus opacification score of ≤ 8 or ≥ 18 measured using the CT derived Lund-Mackay scoring system
- Isolated sinus disease evident on Non-Contrast CT scan that would unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid or frontal disease).
- Polyposis scored as 3 using the Modified Lund-Kennedy Score as follows:
- 3 = Polyps completely obstructing the nose
- Prior ocular and/or sinus surgery that alter the boney anatomy or violate/enter the orbit or sinus (i.e. Fess, balloon sinuplasty). Minor procedures such as septoplasty or turbinectomy are not exclusions.
- Prior surgical history, physical exam, nasal endoscopy, and /or imaging studies that suggest significant craniofacial deformity (such as facial anatomic abnormality from surgical intervention, trauma, and congenital or any other cause thus prohibiting adequate placement of the Sinopsys® Lacrimal Stent).
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- Presence of a sinonasal encepholocele as determined by Non-Contrast CT scan.
- Presence of active HEENT infection including acute dacryocystitis, with the exception of baseline CRS (Chronic Rhinosinusitis) infection.
- Febrile illness within 2 weeks of procedure and/or active pus from nose.
- Any sign of active ophthalmic disease, infection or inflammation including the presence of severe ocular surface inflammatory disease as determined by ophthalmic and 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.
- Underlying medical condition that, in the opinion of the Investigator, would place the subject at high risk if PO or IV sedation (MAC or monitored anesthesia care) were used during the procedure.
- Known silicone allergy
- Documented diagnostic history of Cystic Fibrosis
- Documented history of migraines and/or cluster headaches requiring treatment with anti-migraine medication.
- Documented uncontrolled or poorly controlled seasonal or perennial allergies requiring daily anti-allergy oral, nasal or ophthalmic medications.
- Tobacco, marijuana and /or e-vape inhaler use either currently or during the last 6 months
- Documented history of bleeding disorders, for example, von Willebrand's disease or hemophilia.
- Inability to stop thrombolytics or other anti-platelet medication prior to procedure day including but not limited to Coumadin (warfarin) for 5 days, Plavix (clopidogrel) for 3 days, ASA(aspirin)/NSAIDs/fish oil supplements for 10 days, Xeralta® (rivaroxaban) for 24 hours.
- For contact lens wearers, inability to go without contact lenses for at least 10 days postoperatively.
- Known use of any investigational ocular or sinusitis drug(s) or devices within 30 days prior to enrollment.
- Investigator determination that the potential study subject is unable to comply with study procedures and /or follow-up, or provided informed consent.
- Women of childbearing potential who test positive on the study-required urine pregnancy test and who are unwilling to practice a medically acceptable contraception regimen from screening through week 8 visit. Women who are documented as postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized, do not require testing.
- Severe co-morbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, cognitive function, substance abuse, shortened life expectancy, vulnerable patient population, high surgical risk).
- Currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventioanl Study of the Sinopsys® Lacrimal Stent in Patients With Moderate to Severe Chronic Rhinosinusitis to Evaluate Safety and Performance for Direct Ethmoid Sinus Saline Irrigation and Ophthalmic Antibiotic/Steroid Delivery
The primary objective is to evaluate clinical data related to the safety and performance of the Sinopsys® Lacrimal Stent.
Read the detailed description
The primary objective of this study is to evaluate the safety and performance of the Sinopsys® Lacrimal Stent in the treatment of patients with moderate to severe chronic chronic rhinosinusitis via direct ethmoid sinus saline irrigation and delivery of an ophthalmic antibiotic/steroid drug.
- 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 (Sinopsys® Lacrimal Stent)
The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid access.
| Study group | Role | What they receive |
|---|---|---|
| Synopsis® Lacrimal Stent | Experimental | The Sinopsys® Lacrimal Stent is indicated for use in creating 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.
Demonstration of acute procedural/device success
Success defined as successful placement of the Sinopsys® Lacrimal Stent and ability to create and maintain transcaruncular access to the ethmoid sinus with the Sinopsys® Lacrimal Stent for 8 weeks post procedure.
Measured: 8 Weeks
Evaluation of Clinical Success at Week 1, 4 and 8 weeks
Using sterile saline eye drop irrigation and two 10-Day courses of ophthalmic antibiotic/steroid eye drops, defined as improvement in SNOT (Sino-Nasal Outcome Test)-20 compared to baseline.
Measured: 8 Weeks
Secondary outcomes (1)
Compare performance of Screening, 4, and 8 week follow up Modified Lund Kennedy nasal endoscopy scores
Comparison of Endoscopy and CT scores from Baseline
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study startApr 2016
- Primary completionAug 2016
- Study completionAug 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinopsys Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladan Hrabe, MD, Principal investigator, Charles University, Pilsen Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304951
- Sponsor's protocol ID
- SLSEU01
- Status last verified
- Sep 2018
- First submitted
- 11 Feb 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventioanl Study of the Sinopsys® Lacrimal Stent in Patients With Moderate to Severe Chronic Rhinosinusitis to Evaluate Safety and Performance for Direct Ethmoid Sinus Saline Irrigation and Ophthalmic Antibiotic/Steroid Delivery
- ClinicalTrials.gov ID
- NCT03304951
- Acronym / sponsor ID
- SLSEU01
- Conditions
- Ethmoid Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sinopsys SurgicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Oct 2017 (actual)
- 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 primary objective is to evaluate clinical data related to the safety and performance of the Sinopsys® Lacrimal Stent.
Detailed description
The primary objective of this study is to evaluate the safety and performance of the Sinopsys® Lacrimal Stent in the treatment of patients with moderate to severe chronic chronic rhinosinusitis via direct ethmoid sinus saline irrigation and delivery of an ophthalmic antibiotic/steroid drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synopsis® Lacrimal Stent | Experimental | Device: Sinopsys® Lacrimal StentThe Sinopsys® Lacrimal Stent is indicated for use in creating 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 (13 listed)
- Investigator has determined that the potential study subject has moderate to severe chronic rhino sinusitis with ethmoid involvement and has failed 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 rhino sinusitis (Rosenfeld, et al, 2007)
- 12 weeks or longer of two or more o f the following signs and symptoms:
- SNOT-20 total raw score ≥ 41
- Non-Contrast CT scan (coronal view) confirms depth of olfactory fossa is Keros classification 1or 2 (Gauba, Sleh, Dua, Agarwal, Ell, \& Vize, 2006)
Key exclusion criteria (25 listed)
- Sinus opacification score of ≤ 8 or ≥ 18 measured using the CT derived Lund-Mackay scoring system
- Isolated sinus disease evident on Non-Contrast CT scan that would unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid or frontal disease).
- Polyposis scored as 3 using the Modified Lund-Kennedy Score as follows:
- 3 = Polyps completely obstructing the nose
- Prior ocular and/or sinus surgery that alter the boney anatomy or violate/enter the orbit or sinus (i.e. Fess, balloon sinuplasty). Minor procedures such as septoplasty or turbinectomy are not exclusions.
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: SLS (Sinopsys® Lacrimal Stent)The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid access. | Device | Synopsis® Lacrimal Stent |
Primary outcome
Demonstration of acute procedural/device success
Time frame: 8 Weeks
Success defined as successful placement of the Sinopsys® Lacrimal Stent and ability to create and maintain transcaruncular access to the ethmoid sinus with the Sinopsys® Lacrimal Stent for 8 weeks post procedure.
Evaluation of Clinical Success at Week 1, 4 and 8 weeks
Time frame: 8 Weeks
Using sterile saline eye drop irrigation and two 10-Day courses of ophthalmic antibiotic/steroid eye drops, defined as improvement in SNOT (Sino-Nasal Outcome Test)-20 compared to baseline.
1 secondary outcome
Compare performance of Screening, 4, and 8 week follow up Modified Lund Kennedy nasal endoscopy scores
Time frame: 8 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 6 Sep 2018.
- Individual participant dataSharing planned: No
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.
Vladan Hrabe, MD principal investigator
Charles University, Pilsen Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinopsys® Lacrimal Stent in people with Ethmoid Sinusitis, run by Sinopsys Surgical at 1 site in Czechia.
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 13 inclusion and 25 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 Sep 2018. 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 Czechia. 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?
Demonstration of acute procedural/device success (time frame: 8 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?
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 Sep 2018; AzTrials last refreshed its copy on 30 Oct 2026.