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

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ClinicalTrials.gov Identifier: NCT03358329
Recruitment Status : Active, not recruiting
First Posted : November 30, 2017
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Intersect ENT

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Sinusitis Nasal Polyposis Combination Product: S8 Sinus Implant Phase 3

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : January 3, 2018
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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


Locations
United States, California
Sacramento ENT
Sacramento, California, United States, 95815
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Illinois
DuPage Medical Group
Naperville, Illinois, United States, 60540
United States, Kentucky
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40207
United States, Louisiana
Associated Surgical Specialists
Covington, Louisiana, United States, 70433
United States, New Mexico
BreatheAmerica of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, New York
Madison ENT
New York, New York, United States, 10016
United States, North Carolina
Charlotte Eye, Ear, Nose and Throat Associates
Concord, North Carolina, United States, 29025
United States, Utah
Bridgerland Clinical Research
North Logan, Utah, United States, 84341
Sponsors and Collaborators
Intersect ENT
Investigators
Principal Investigator: Peter Manes, MD Yale Medical Group

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT03358329     History of Changes
Other Study ID Numbers: P500-0717
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
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