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Lacrimal Stent

Sinopsys Lacrimal Stent for Sinus Infection (SLS Trial)

Phase < 1
Waitlist Available
Research Sponsored by Sinopsys Surgical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks
Awards & highlights

Summary

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

Eligible Conditions
  • Sinus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
SNOT - 20
Safety: Incidence and occurrence of anticipated and unanticipated adverse events
Secondary outcome measures
Lund-Kennedy Nasal Endoscopy Scores
Lund-MacKay CT Scores

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sinopsys Lacrimal StentExperimental Treatment1 Intervention
The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sinopsys Lacrimal Stent
2015
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

Sinopsys SurgicalLead Sponsor
3 Previous Clinical Trials
22 Total Patients Enrolled
Teena AugustinoStudy DirectorSinopsys Surgical Inc.
~1 spots leftby Aug 2025
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