NCT03066908

Suspended

Sinopsys Lacrimal Stent Study for Patients With Chronic Sinu...

Sinopsys Surgical Source

Sinopsys Surgical ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

SLSUS05

Study Type

interventional

Actual enrollment (reported)

4

Locations

1 country

Sites

6

Timeline

Study Start

April 20, 2017

Actual (reported)

Primary Completion

October 31, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

October 31, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

A prospective, single arm, multicenter study designed to demonstrate that the Sinopsys® Lacrimal Stent can safely create transcaruncular access to the ethmoid sinus to enable sinus irrigation and reduce symptoms in patients with moderate to severe chronic rhinosinusitis.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: suspended
Actual enrollment (reported): 4 participants
Study completion date: October 31, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 6 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 17, 2017
Actual (reported)
First Posted
March 1, 2017
Actual (reported)
Study Start
April 20, 2017
Actual (reported)
Primary Completion
October 31, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 31, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: September 26, 2023
Status Verified: September 2023
Last Update Submitted: September 25, 2023

Conditions

Chronic Sinus Infection

Keywords

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

Zinreich CT Score
The average change in the Zinreich modified Lund-Mackay scoring of CTs (Zinreich Modified CT) from screening to 12 Weeks
12 Weeks

Secondary Outcomes (1)

SNOT-22 Score
12 Weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Sinopsys® Lacrimal Stent

Device: Sinopsys® Lacrimal Stent

Interventions

Sinopsys® Lacrimal StentDevice

Transcaruncular paranasal sinus or nasal cavity access for the purpose of irrigating the ethmoid sinus with saline

Also known as: SLS

Single Arm

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:
Non-Contrast CT scan (coronal view) Total Zinreich Modified CT score of 10-41

Sponsors & Collaborators

Sinopsys Surgical
Industrylead

Study Sites (6)

Front Range ENT

Greeley, Colorado, 80634, United States

Ear, Nose & Throat Associates of South Florida

Boca Raton, Florida, 33487, United States

Kentuckiana Ear, Nose & Throat, PSC

Louisville, Kentucky, 40205, United States

The Rontal Clinic

Farmington Hills, Michigan, 48334, United States

Madison ENT

New York, New York, 10016, United States

EVMS Otolaryngology

Norfolk, Virginia, 23507, United States

Study Officials

Joel Hale
Sinopsys Surgical
STUDY DIRECTOR

Enrollment

4 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 17, 2017

First Posted

March 1, 2017

Study Start

April 20, 2017

Actual (reported)

NCT03809312

The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp

Phase 4Unknown

NCT02972281

Systematic Search for Primary Immunodeficiency in Adults With Infections

Not ApplicableCompleted

NCT03519061

Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates

Phase 2/3Withdrawn

Inflammation/ involvement of the ethmoid sinus with left and/or right anterior ethmoid and/or posterior ethmoid Zinreich Modified CT scores of 1-4

SNOT-22 total raw score ≥ 45

Meets the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) criteria for chronic rhinosinusitis (CRS) (Rosenfeld, et al., 2007): 90 days 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

Has failed medical therapy (Rudmik, et al., 2016) defined as the following:

During the 90 days prior to enrollment, at a minimum:

One course of broad spectrum or culture directed oral antibiotic of at least 2 weeks duration 60 days of topical intranasal steroid therapy and; 30 days of saline irrigation

Age ≥ 22 years

Non-Contrast CT scan (coronal view) confirms depth of olfactory fossa is Keros classification type 1 or 2

The potential study subject is capable of understanding and executing written informed consent (IC) and questionnaires/diaries in English

You may not qualify if:

Sinus opacification score of \<10 or \> 41 measured using the Zinreich Modified CT scoring system
Isolated sinus disease evident on Non-Contrast CT scan that would be unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid, maxillary or frontal disease)
Polyposis scored as 2 using the Modified Lund-Kennedy Score
Non-Contrast CT scan (coronal view) shows depth of olfactory fossa is Keros classification type 3
Prior surgical history, physical exam, nasal endoscopy and/or imaging studies that suggest significant craniofacial deformity (such as any facial anatomic abnormality from surgical intervention, trauma, and congenital or any other cause thus prohibiting adequate placement of the Sinopsys Lacrimal Stent
Presence of a sinonasal encepholocele as determined by Non-Contrast CT scan
Presence of active HEENT infection including acute dacryocystitis, with the exception of CRS infection
Febrile illness within 2 weeks of procedure and/or active pus from nose
Any sign of active ophthalmic disease, infection, or inflammation including the presence of severe ocular surface inflammatory disease as determined by ophthalmic and physical exam, which could be exacerbated by the presence of the device
Best Corrected Visual Acuity (BCVA) worse than 20/50
Dry Eye disease defined by the following:
Abnormal Tear Breakup Test (TBUT) (\< 5 seconds) in either eye and
Corneal staining showing superficial punctate keratopathy of Grade 1 or higher in either eye at Screening Visit
Use of topical or systemic prescription ocular medications, except rewetting drops for contact lens-related discomfort, for the eye to treat an active ophthalmic disease at or within 14 days of screening and through procedure
Underlying medical condition that, in the opinion of the Investigator, would place the subject at high risk if IV sedation (MAC or monitored anesthesia care) were used during the procedure
+15 more criteria

Contact the study team to confirm eligibility.

Primary Completion

October 31, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

October 31, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03066908
Data provider: ClinicalTrials.gov
Source updated: 2023-09-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:17 UTC

Locations

US(6)

Study Stopped

Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Single Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

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

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Single Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations