Sinopsys Lacrimal Stent Indicated for Sinus Irrigation (SLS)

February 11, 2016 updated by: Sinopsys Surgical

The Sinopsys Lacrimal Stent Indicated for Sinus Irrigation Via Transcaruncular Ethmoid Sinus Access in Patients With Moderate to Severe Chronic Rhinosinusitis With Ethmoid Sinus Involvement

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For purposes of this clinical study, the Sinopsys Lacrimal Stent is intended to provide a means of administering saline sinus irrigation via a transcaruncular-ethmoid sinus access in patients with moderate to severe chronic rhinosinusitis with ethmoid involvement. The purpose of the administration of saline irrigation is to reduce the intensity of symptoms of chronic rhinosinusitis in this patient population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Greeley, Colorado, United States, 80634
        • Front Range ENT
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Advanced ENT and Allergy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Age ≥ 22 years

  3. 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
  4. SNOT-20 total score ≥ 41
  5. CT scan (coronal view) confirms inflammation / involvement of the ethmoid sinuses
  6. CT scan (coronal view) confirms depth of olfactory fossa is Keros classification 1 or 2.

Exclusion Criteria:

  1. Sinus opacification score of ≤ 8 or ≥ 18 measured using the CT derived Lund -- Mackay scoring system
  2. Isolated sinus disease evident on CT scan that would be unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid or frontal disease)
  3. Severe polyposis defined as Grade III or Grade IV polyposis using the adapted scale from Meltzer, 2006.
  4. Prior ocular and/or sinus surgery for CRS
  5. CT scan (coronal view) shows depth of olfactory fossa is Keros classification 3.
  6. 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
  7. Presence of a sinonasal encepholocele as determined by CT scan
  8. Presence of active HEENT infection including acute dacryocystitis
  9. Febrile illness within 2 weeks and/or active pus from nose
  10. 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
  11. Current use of topical medications for the eye to treat an active ophthalmic disease
  12. HbA1c level of ≥ 7.5% at the time of screening, current chemotherapy, or other immune compromised conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Sinopsys Lacrimal Stent
The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.
Device: Sinopsys Lacrimal Stent
The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.
Other Names:
  • SLS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SNOT - 20
Time Frame: 18 Weeks
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.
Time Frame: 18 Weeks
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
Time Frame: 18 Weeks
Assessment of the incidence and occurrence of anticipated and unanticipated adverse events reported during the 18 weeks of the clinical study.
18 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lund-MacKay CT Scores
Time Frame: 12 Weeks
Comparison of baseline and 12 weeks
12 Weeks
Lund-Kennedy Nasal Endoscopy Scores
Time Frame: 12 Weeks
Comparison of baseline and 12 weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinopsys Surgical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Teena Augustino, Sinopsys Surgical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLS-US-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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