Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS

NCT03066908 | Suspended DMC FDA Device

• 1 other identifier: SLSUS05
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Chronic Sinus Infection

Keywords

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Zinreich CT Score

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

  12 Weeks

Secondary Outcomes (1)

• SNOT-22 Score

  12 Weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Sinopsys® Lacrimal Stent

Device: Sinopsys® Lacrimal Stent

Interventions

Sinopsys® Lacrimal Stent DEVICE

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

Also known as: SLS

Single Arm

Eligibility Criteria

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

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Sinopsys Surgical: lead

Study Sites (6)

Front Range ENT

Greeley, Colorado, 80634, United States

Location

Ear, Nose & Throat Associates of South Florida

Boca Raton, Florida, 33487, United States

Location

Kentuckiana Ear, Nose & Throat, PSC

Louisville, Kentucky, 40205, United States

Location

The Rontal Clinic

Farmington Hills, Michigan, 48334, United States

Location

Madison ENT

New York, New York, 10016, United States

Location

EVMS Otolaryngology

Norfolk, Virginia, 23507, United States

Location

Study Officials

• Joel Hale

  Sinopsys Surgical

  STUDY DIRECTOR

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 17, 2017
• First Posted: March 1, 2017
• Study Start: April 20, 2017
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)