CompletedEarly Phase 1

Sinopsys Lacrimal Stent Indicated for Sinus Irrigation

United States9 participantsStarted 2015-03

Plain-language summary

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

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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

What they're measuring

SNOT - 20

Timeframe: 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.

Timeframe: 18 Weeks

Safety: Incidence and occurrence of anticipated and unanticipated adverse events

Timeframe: 18 Weeks

Trial details

NCT IDNCT02297243

SponsorSinopsys Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02

View on ClinicalTrials.gov More Ethmoid Sinusitis trials

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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

What they're measuring

SNOT - 20

Timeframe: 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.

Timeframe: 18 Weeks

Safety: Incidence and occurrence of anticipated and unanticipated adverse events

Timeframe: 18 Weeks