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Chronic Sinus InfectionCRSNCT03066908

Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS

A study testing Sinopsys® Lacrimal Stent in people with Chronic Sinus Infection, run by Sinopsys Surgical at 6 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

A prospective, single arm, multicenter study designed to demonstrate that the Sinopsys® Lacrimal Stent can safely create transcaruncular access to the ethmoid sinus to enable sinus irrigation and reduce symptoms in patients with moderate to severe chronic rhinosinusitis. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Chronic Sinus Infection
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
4 participants
Where
6 sitesUnited States
Study dates
20 Apr 2017to 31 Oct 2024
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

  • The Investigator has determined that the potential study subject has moderate to severe chronic rhinosinusitis with ethmoid involvement:
  • Non-Contrast CT scan (coronal view) Total Zinreich Modified CT score of 10-41
  • Inflammation/ involvement of the ethmoid sinus with left and/or right anterior ethmoid and/or posterior ethmoid Zinreich Modified CT scores of 1-4
  • SNOT-22 total raw score ≥ 45
  • Meets the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) criteria for chronic rhinosinusitis (CRS) (Rosenfeld, et al., 2007): 90 days 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 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
  • Has failed medical therapy (Rudmik, et al., 2016) defined as the following:
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  • During the 90 days prior to enrollment, at a minimum:
  • One course of broad spectrum or culture directed oral antibiotic of at least 2 weeks duration 60 days of topical intranasal steroid therapy and; 30 days of saline irrigation
  • Age ≥ 22 years
  • Non-Contrast CT scan (coronal view) confirms depth of olfactory fossa is Keros classification type 1 or 2
  • The potential study subject is capable of understanding and executing written informed consent (IC) and questionnaires/diaries in English

Who cannot join

  • Sinus opacification score of <10 or > 41 measured using the Zinreich Modified CT scoring system
  • Isolated sinus disease evident on Non-Contrast CT scan that would be unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid, maxillary or frontal disease)
  • Polyposis scored as 2 using the Modified Lund-Kennedy Score
  • Prior ocular and/or sinus surgery that alter the boney anatomy or violate/enter the orbit or sinus in a way that would render these structures "non-intact" (i.e. FESS). Minor procedures such as balloon sinus dilation (>30 days), septoplasty or turbinectomy are not exclusions.
  • Non-Contrast CT scan (coronal view) shows depth of olfactory fossa is Keros classification type 3
  • Prior surgical history, physical exam, nasal endoscopy and/or imaging studies that suggest significant craniofacial deformity (such as any 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 CRS 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
  • Best Corrected Visual Acuity (BCVA) worse than 20/50
  • Dry Eye disease defined by the following:
  • Abnormal Tear Breakup Test (TBUT) (< 5 seconds) in either eye and
  • Corneal staining showing superficial punctate keratopathy of Grade 1 or higher in either eye at Screening Visit
  • Use of topical or systemic prescription ocular medications, except rewetting drops for contact lens-related discomfort, for the eye to treat an active ophthalmic disease at or within 14 days of screening and through procedure
  • Underlying medical condition that, in the opinion of the Investigator, would place the subject at high risk if IV sedation (MAC or monitored anesthesia care) were used during the procedure
  • Excessive ocular and/or adipose tissue that may obscure implanted device visualization and/or placement
  • Known allergies to silicone, TobraDex® (Tobramycin and Dexamethasone), procedural medications, and ophthalmic eye drops (required for routine eye exams)
  • Documented diagnostic history of Cystic Fibrosis
  • Documented history of migraines, cluster headaches, chronic daily headaches or other headaches unrelated to the sinus
  • Documented uncontrolled or poorly controlled seasonal or perennial allergies
  • Requires any amount of concurrent systemic steroid medication for chronic illness such as auto-immune diseases
  • Tobacco, marijuana and/or e-vape inhaler use either currently or during the last 90 days
  • 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/NSAIDs/fish oil supplements for 10 days, Xarelto® (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 sinus 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 provide informed consent
  • Women of childbearing potential who test positive on the study-required urine pregnancy test or who are unwilling to practice a medically acceptable contraception regimen from Screening Visit though Week 12 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 this clinical study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Ear, Nose & Throat Associates of South Florida

    Boca Raton, Florida, 33487

  • The Rontal Clinic

    Farmington Hills, Michigan, 48334

  • Front Range ENT

    Greeley, Colorado, 80634

  • Kentuckiana Ear, Nose & Throat, PSC

    Louisville, Kentucky, 40205

  • Madison ENT

    New York, New York, 10016

  • EVMS Otolaryngology

    Norfolk, Virginia, 23507

Other trials in United States

About this study

Official title: A Prospective, Single Arm, Multicenter Study of the Sinopsys® Lacrimal Stent Used for Transcaruncular-Ethmoid Sinus Access and Saline Irrigation in Patients With Moderate to Severe Chronic Rhinosinusitis

A prospective, single arm, multicenter study designed to demonstrate that the Sinopsys® Lacrimal Stent can safely create transcaruncular access to the ethmoid sinus to enable sinus irrigation and reduce symptoms in patients with moderate to severe chronic rhinosinusitis.

Being tested
Sinopsys® Lacrimal Stent
Keywords
Chronic Rhinosinusitis

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

    Transcaruncular paranasal sinus or nasal cavity access for the purpose of irrigating the ethmoid sinus with saline

Study groups in NCT03066908
Study groupRoleWhat they receive
Single ArmExperimentalSinopsys® Lacrimal Stent
Receives: Device: Sinopsys® Lacrimal Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Zinreich CT Score

    The average change in the Zinreich modified Lund-Mackay scoring of CTs (Zinreich Modified CT) from screening to 12 Weeks

    Measured: 12 Weeks

Secondary outcomes (1)

  1. SNOT-22 Score

    Intermediate changes from Screening in the Total SNOT-22 will be calculated from screening to 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.

  1. First posted1 Mar 2017
  2. Study start20 Apr 2017
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Oct 2024 (estimated)

Why it stopped: Change in study design

Resources

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03066908
Sponsor's protocol ID
SLSUS05
Acronym
CRS
Status last verified
Sep 2023
First submitted
17 Feb 2017
Last updated
26 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sinopsys® Lacrimal Stent in people with Chronic Sinus Infection, run by Sinopsys Surgical at 6 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 11 inclusion and 31 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: paused, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

Results are not available in the source record.

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?

Zinreich CT Score (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03066908.

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 26 Sep 2023.

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