Sinopsys® Lacrimal Stent Indicated for Sinus Irrigation

NCT03304951 | Completed

• 1 other identifier: SLSEU01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate clinical data related to the safety and performance of the Sinopsys® Lacrimal Stent.

Conditions

Ethmoid Sinusitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8 Weeks

Secondary Outcomes (1)

• Compare performance of Screening, 4, and 8 week follow up Modified Lund Kennedy nasal endoscopy scores

  8 Weeks

Study Arms (1)

Synopsis® Lacrimal Stent

EXPERIMENTAL

The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid sinus access

Device: Sinopsys® Lacrimal Stent

Interventions

Sinopsys® Lacrimal Stent DEVICE

The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid access.

Also known as: SLS (Sinopsys® Lacrimal Stent)

Synopsis® Lacrimal Stent

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• 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)

You may not qualify if:

• 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:
• = Polyps completely obstructing the nose
• 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).
• 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.

Sponsors & Collaborators

• Sinopsys Surgical: lead

Study Sites (1)

Charles University Faculty of Medicine

Pilsen, 30599, Czechia

Location

MeSH Terms

Conditions

Ethmoid Sinusitis

Condition Hierarchy (Ancestors)

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Vladan Hrabe, MD

  Charles University, Pilsen Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: October 9, 2017
• Study Start: April 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)