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Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS (CRS)

This study is currently recruiting participants.
Verified September 2017 by Sinopsys Surgical
Sponsor:
ClinicalTrials.gov Identifier:
NCT03066908
First Posted: March 1, 2017
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sinopsys Surgical
  Purpose
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.

Condition Intervention
Chronic Sinus Infection Device: Sinopsys® Lacrimal Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single Arm, Multicenter Study of the Sinopsys® Lacrimal Stent Used for Transcaruncular-Ethmoid Sinus Access and Saline Irrigation in Patients With Moderate to Severe Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by Sinopsys Surgical:

Primary Outcome Measures:
  • Zinreich CT Score [ Time Frame: 12 Weeks ]
    The average change in the Zinreich modified Lund-Mackay scoring of CTs (Zinreich Modified CT) from screening to 12 Weeks


Secondary Outcome Measures:
  • SNOT-22 Score [ Time Frame: 12 Weeks ]
    Intermediate changes from Screening in the Total SNOT-22 will be calculated from screening to 12 weeks


Estimated Enrollment: 66
Actual Study Start Date: February 20, 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Sinopsys® Lacrimal Stent
Device: Sinopsys® Lacrimal Stent
Transcaruncular paranasal sinus or nasal cavity access for the purpose of irrigating the ethmoid sinus with saline
Other Name: SLS

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • Prior ocular and/or sinus surgery that alter the boney anatomy or violate/enter the orbit or sinus in a way that would render these structures "non-intact" (i.e. FESS). Minor procedures such as balloon sinus dilation (>30 days), septoplasty or turbinectomy are not exclusions.
  • 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
  • Excessive ocular and/or adipose tissue that may obscure implanted device visualization and/or placement
  • Known allergies to silicone, TobraDex® (Tobramycin and Dexamethasone), procedural medications, and ophthalmic eye drops (required for routine eye exams)
  • Documented diagnostic history of Cystic Fibrosis
  • Documented history of migraines, cluster headaches, chronic daily headaches or other headaches unrelated to the sinus
  • Documented uncontrolled or poorly controlled seasonal or perennial allergies
  • Requires any amount of concurrent systemic steroid medication for chronic illness such as auto-immune diseases
  • Tobacco, marijuana and/or e-vape inhaler use either currently or during the last 90 days
  • Documented history of bleeding disorders, for example, von Willebrand's disease or hemophilia
  • Inability to stop thrombolytics or other anti-platelet medication prior to procedure day including but not limited to Coumadin (warfarin) for 5 days, Plavix (clopidogrel) for 3 days, ASA/NSAIDs/fish oil supplements for 10 days, Xarelto® (rivaroxaban) for 24 hours
  • For contact lens wearers, inability to go without contact lenses for at least 10 days postoperatively
  • Known use of any investigational ocular or sinus drug(s) or devices within 30 days prior to enrollment
  • Investigator determination that the potential study subject is unable to comply with study procedures and/or follow-up, or provide informed consent
  • Women of childbearing potential who test positive on the study-required urine pregnancy test or who are unwilling to practice a medically acceptable contraception regimen from Screening Visit though Week 12 visit. Women who are documented as postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require testing
  • Severe co-morbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, cognitive function, substance abuse, shortened life expectancy, vulnerable patient population, high surgical risk)
  • Currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066908


Contacts
Contact: Joel Hale 303-674-1221 joel@sinopsyssurgical.com
Contact: Monica Kellogg monica@sinopsyssurgical.com

Locations
United States, Colorado
Front Range ENT Recruiting
Greeley, Colorado, United States, 80634
Contact: Lori Malone    970-330-5555    lmalone@frontrangeent.com   
Principal Investigator: Sanjay Gupta, MD         
United States, District of Columbia
Medical Faculty Associates at George Washington University Recruiting
Washington, D.C., District of Columbia, United States, 20037
Contact: Jonise Handy-Richards    202-677-6381    jhandy@mfa.gwu.edu   
Principal Investigator: Ameet Singh, MD         
United States, Florida
Ear, Nose & Throat Associates of South Florida Recruiting
Boca Raton, Florida, United States, 33487
Contact: Dawn Villacci    561-939-0177    dvillacci@entsf.com   
Principal Investigator: Nathan E Nachlas, MD         
United States, Kentucky
Kentuckiana Ear, Nose & Throat, PSC Recruiting
Louisville, Kentucky, United States, 40205
Contact: Laticia Edelen    502-894-8441 ext 211    ledelen@kentuckianaent.com   
Principal Investigator: Thomas Higgins, MD         
United States, Michigan
The Rontal Clinic Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Laura Good, PA    248-737-4030    lgood262@gmail.com   
Principal Investigator: Daniel Rontal, MD         
United States, New York
Madison ENT Recruiting
New York, New York, United States, 10016
Contact: Christine Chung    212-792-6594    cchung@madison-ent.com   
Principal Investigator: Stacey Silvers, MD         
United States, Virginia
EVMS Otolaryngology Recruiting
Norfolk, Virginia, United States, 23507
Contact: Laura J Stone, RN, BSN    757-388-6238    StoneLJ@evms.edu   
Principal Investigator: Joseph K Han, MD         
Sponsors and Collaborators
Sinopsys Surgical
Investigators
Study Director: Joel Hale Sinopsys Surgical
  More Information

Responsible Party: Sinopsys Surgical
ClinicalTrials.gov Identifier: NCT03066908     History of Changes
Other Study ID Numbers: SLSUS05
First Submitted: February 17, 2017
First Posted: March 1, 2017
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Sinopsys Surgical:
Chronic Rhinosinusitis

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases