Trials Sponsors Conditions Drugs Pricing

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 StentDevice

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

Also known as: SLS

Sinopsys Lacrimal Stent

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age22 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Sinopsys Surgical
Industrylead

Study Sites (3)

Stanford University

Stanford, California, 94305, United States

Front Range ENT

Greeley, Colorado, 80634, United States

Advanced ENT and Allergy

Louisville, Kentucky, 40207, United States

MeSH Terms

Conditions

Ethmoid Sinusitis

Condition Hierarchy (Ancestors)

SinusitisRespiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

Teena Augustino
Sinopsys Surgical Inc.
STUDY DIRECTOR

Enrollment

9 participants (actual enrollment reported by the registry).

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 2015

Date type not reported

This date has not been verified as actual or estimated.

Sinopsys Lacrimal Stent Indicated for Sinus Irrigation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (1)

Sinopsys Lacrimal Stent

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (1)

Sinopsys Lacrimal Stent

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations