Sinopsys Lacrimal Stent Indicated for Sinus Irrigation

NCT02297243 | Completed Early Phase 1

• 1 other identifier: SLS-US-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.

Conditions

Ethmoid Sinusitis

Outcome Measures

Primary Outcomes (3)

• SNOT - 20

  Chronic Rhinosinusitis symptoms as measured by SNOT-20 scores from baseline to 18 weeks follow-up (1, 4, 8, 12, and 18)

  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.

  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.

  18 Weeks

Secondary Outcomes (2)

• Lund-MacKay CT Scores

  12 Weeks

• Lund-Kennedy Nasal Endoscopy Scores

  12 Weeks

Study Arms (1)

Sinopsys Lacrimal Stent

EXPERIMENTAL

The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.

Device: Sinopsys Lacrimal Stent

Interventions

Sinopsys Lacrimal Stent DEVICE

The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.

Also known as: SLS

Sinopsys Lacrimal Stent

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 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
• 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.

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 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
• 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

Sponsors & Collaborators

• Sinopsys Surgical: lead

Study Sites (3)

Stanford University

Stanford, California, 94305, United States

Location

Front Range ENT

Greeley, Colorado, 80634, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40207, United States

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

• Teena Augustino

  Sinopsys Surgical Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 21, 2014
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

US (3)