Trials Sponsors Conditions Drugs Pricing

Conditions

Ethmoid Sinusitis

Outcome Measures

Primary Outcomes (2)

Demonstration of acute procedural/device success
Success defined as successful placement of the Sinopsys® Lacrimal Stent and ability to create and maintain transcaruncular access to the ethmoid sinus with the Sinopsys® Lacrimal Stent for 8 weeks post procedure.
8 Weeks
Evaluation of Clinical Success at Week 1, 4 and 8 weeks
Using sterile saline eye drop irrigation and two 10-Day courses of ophthalmic antibiotic/steroid eye drops, defined as improvement in SNOT (Sino-Nasal Outcome Test)-20 compared to baseline.
8 Weeks

Secondary Outcomes (1)

Compare performance of Screening, 4, and 8 week follow up Modified Lund Kennedy nasal endoscopy scores
8 Weeks

Study Arms (1)

Synopsis® Lacrimal Stent

EXPERIMENTAL

The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid sinus access

Device: Sinopsys® Lacrimal Stent

Interventions

Sinopsys® Lacrimal StentDevice

The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid access.

Also known as: SLS (Sinopsys® Lacrimal Stent)

Synopsis® 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:

Investigator has determined that the potential study subject has moderate to severe chronic rhino sinusitis with ethmoid involvement and has failed 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 rhino sinusitis (Rosenfeld, et al, 2007)

Sponsors & Collaborators

Sinopsys Surgical
Industrylead

Study Sites (1)

Charles University Faculty of Medicine

Pilsen, 30599, Czechia

MeSH Terms

Conditions

Ethmoid Sinusitis

Condition Hierarchy (Ancestors)

SinusitisRespiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

Vladan Hrabe, MD
Charles University, Pilsen Czech Republic
PRINCIPAL INVESTIGATOR

Enrollment

8 participants (actual enrollment reported by the registry).

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 11, 2017

First Posted

October 9, 2017

Study Start

April 2016

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

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Synopsis® Lacrimal Stent

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Synopsis® Lacrimal Stent

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations