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Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)

This study is currently recruiting participants.
Verified November 2017 by Intersect ENT
Sponsor:
ClinicalTrials.gov Identifier:
NCT03358329
First Posted: November 30, 2017
Last Update Posted: December 1, 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):
Intersect ENT
  Purpose
The ENCORE Study is a non-randomized, open-label, multicenter study with 50 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.

Condition Intervention Phase
Chronic Sinusitis Nasal Polyposis Combination Product: S8 Sinus Implant Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ENCORE Study: Safety Evaluation of Repeat Placement of the Corticosteroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps

Resource links provided by NLM:


Further study details as provided by Intersect ENT:

Primary Outcome Measures:
  • Primary Outcome Measure: [ Time Frame: 365 Day ]
    Safety Evaluation: All AE's reported by subjects between consent and the Day 365 follow-up visit (end of study) will be tabulated.


Estimated Enrollment: 50
Actual Study Start Date: November 13, 2017
Estimated Study Completion Date: March 15, 2019
Estimated Primary Completion Date: March 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S8 Sinus Implant
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Combination Product: S8 Sinus Implant
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Detailed Description:

The ENCORE Study is a prospective non-randomized, open-label, multicenter trial conducted in up to 10 clinical centers (academic and private) across the United States in 50 adults with chronic sinusitis, who are indicated for revision surgery because of recurring nasal obstruction/congestion symptoms and bilateral ethmoid polyposis.

This study will assess the safety of repeat placement of the S8 Sinus Implant when used in chronic sinusitis (CS) patients with recurrent nasal polyps

  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:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patient has provided written informed consent using a form approved by the reviewing institutional review board (IRB) and sponsor.
  2. Patient is ≥ 18 years of age.
  3. Patient is willing and able to comply with protocol requirements.
  4. Patient has a confirmed diagnosis of CS with nasal polyps, as defined in the 2016 "International Consensus Statement on Allergy and Rhinology".
  5. Patient has undergone prior ESS including bilateral total ethmoidectomy at least 90 days prior to screening.
  6. Patient has evidence of bilateral ethmoid sinus obstruction due to polyposis warranting intervention (polyp grade ≥ 2 on each side).
  7. Patient is able to tolerate daily use of Mometasone Furoate Nasal Spray (MFNS).
  8. Patient is able to tolerate topical/local anesthesia.
  9. In the opinion of the investigator, patient's ethmoid sinus anatomy is amenable to in-office bilateral placement of the S8 Sinus Implant (i.e., able to pass into the middle meatus on both sides the S8 Sinus Implant with 20 mm in nominal length and 7 mm in compressed diameter).
  10. Female patients of reproductive potential must not be pregnant or nursing and must agree to not become pregnant during their participation in the study.
  11. Female patients of childbearing potential must agree to use consistent and acceptable method(s) of birth control during their participation in the study.

Exclusion Criteria:

  1. Patient has extensive ethmoid sinus polyp grade (grade 4 on at least one side).
  2. Patient has extensive adhesions/synechiae (grade 3 or 4).
  3. Patient has used parenteral and injected steroids (e.g., Kenalog injection) during 30 days prior to the baseline procedure.
  4. Patient has used oral steroids, budesonide or other sinus steroid irrigations/rinses, nebulized steroids administered nasally or budesonide drops during 14 days prior to the baseline procedure.
  5. Patient has oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or asthma.
  6. Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate.
  7. Patient has used monoclonal antibodies for asthma, allergies or nasal polyps (e.g., Dupixent, Nucala, Xolair) during 30 days prior to the baseline procedure.
  8. Patient requires monoclonal antibodies for asthma, allergies or nasal polyps during the duration of the study.
  9. Patient has presence of physical obstruction that would preclude access and placement of the S8 Sinus Implant in the middle meatus (e.g., severe septal deviation, septal spur, very small middle meatus, total obstruction of the sinonasal passage with severe adhesion, scarring, polypoid edema or polyps).
  10. Patient has known history of human immunodeficiency virus (HIV) or immunoglobulin G or A subclass deficiency.
  11. Patient has clinical evidence of acute sinusitis (AS), as defined in the 2016 "International Consensus Statement on Allergy and Rhinology".
  12. Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on prior computed tomography (CT) scan, necrotic sinus tissue).
  13. Patient has evidence of severe concomitant disease or condition expected to compromise survival or ability to complete assessments during the 365-day study follow-up period (e.g., cancer).
  14. Patient is currently participating in another clinical study.
  15. Patient has previously undergone ESS and experienced a cerebrospinal fluid (CSF) leak or has residual compromised vision as a result of a complication in a prior ESS procedure.
  16. Patient has known dehiscence of the lamina papyracea.
  17. Patient has evidence of active tuberculosis or active viral illness (e.g., ocular herpes simplex, chickenpox, measles).
  18. Patient has known history or diagnosis of glaucoma or ocular hypertension (prior ocular exam with intraocular pressure of >21 mmHg and pressure lowering medication given) or posterior subcapsular cataract.
  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): NCT03358329


Contacts
Contact: Nicole Van Houten, RN 404-772-2031 nvhouten@intersectENT.com
Contact: Chris Lewis, MS 423-598-6681 clewis@intersectent.com

Locations
United States, California
Sacramento ENT Recruiting
Sacramento, California, United States, 95815
Contact: Rose Khalatyan    916-736-3399 ext 1101    vkhalatyan@sacent.com   
Principal Investigator: Randall Ow, MD         
United States, Connecticut
Yale University School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06519
Contact: Sherrie Bitterman    203-584-8404    sherrie.bitterman@yale.edu   
Principal Investigator: Peter Manes, MD         
United States, Illinois
DuPage Medical Group Not yet recruiting
Naperville, Illinois, United States, 60540
Contact: Janet Moffat    630-456-7228    janet.moffat@dupagemd.com   
Principal Investigator: Feodor Ung, MD         
United States, Kentucky
Advanced ENT & Allergy Recruiting
Louisville, Kentucky, United States, 40207
Contact: Kathleen Sheeley    502-893-0159    ksheeley@advancedentandallergy.com   
Principal Investigator: Andrew R Gould, MD         
United States, Louisiana
Associated Surgical Specialists Recruiting
Covington, Louisiana, United States, 70433
Contact: Julie Salazar    985-845-2677      
Contact       toro654@yahoo.com   
Principal Investigator: Kevin McLaughlin, MD         
United States, New Mexico
BreatheAmerica of Albuquerque Not yet recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Laure Jones    505-944-9599    ljones@breatheamerica.com   
Principal Investigator: Roland Gerencer, MD         
United States, New York
Madison ENT Recruiting
New York, New York, United States, 10016
Contact: Christine Chung    212-213-3339    cchung@madison-ent.com   
Principal Investigator: Stacey Silvers, MD         
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Sean McKee    412-735-6516    sean.mckee@mountsinai.org   
Principal Investigator: Mark Iloreta, MD         
United States, North Carolina
Charlotte Eye, Ear, Nose and Throat Associates Not yet recruiting
Concord, North Carolina, United States, 29025
Contact: Christy Flemming    704-295-3393    aprice@ceenta.com   
Principal Investigator: F. Johns Langford, M.D.         
United States, Utah
Bridgerland Clinical Research Recruiting
North Logan, Utah, United States, 84341
Contact: Jessica Koh    435-363-7700    jk@bridgerlandresearch.com   
Principal Investigator: Jeffrey Bennion, MD         
Sponsors and Collaborators
Intersect ENT
Investigators
Principal Investigator: Peter Manes, MD Yale Medical Group
  More Information

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT03358329     History of Changes
Other Study ID Numbers: P500-0717
First Submitted: November 27, 2017
First Posted: November 30, 2017
Last Update Posted: December 1, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents