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

The ENCORE Study: Safety Evaluation of Repeat Placement of the Corticosteroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps

The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis; Nasal Polyposis
• Intervention / Treatment: Combination product: S8 Sinus Implant

Detailed Description

The ENCORE Study is a prospective open-label, non-randomized, multicenter study in CS patients who had undergone prior endoscopic sinus surgery (ESS) including bilateral total ethmoidectomy and present with bilateral ethmoid polyposis.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S8 Sinus Implant; corticosteroid-eluting sinus implant containing 1350 mcg of mometasone furoate (MF)	Combination product: S8 Sinus Implant; In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Implant-Related Serious Adverse Events	Evaluated via tabulation of implant-related serious adverse events (SAE) reported by subjects between consent and Day 365.	365 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNOT-22 Total Score	Sino-Nasal Outcomes Test (SNOT-22) is a validated disease-specific symptom-scoring instrument consisting of 22 questions, each scored on a 6-point scale of 0 (no problem) to 5 (probably as bad as it can be) based on the subject's recollection of symptoms over the past 2 weeks. The total score ranges from 0 to 110, with a higher score reflecting greater symptom burden. Change from baseline to 90 days and to 180 days is calculated as the value at 90/180 days minus the value from baseline. Negative values for change from baseline indicate reduction (improvement) in sino-nasal symptoms.	Baseline, 90 days, 180 days
Nasal Obstruction/Congestion Score	Determined on a scale of 0 (no symptoms) to 3 (severe symptoms) based on the subject's recollection of symptoms over the past week using a reflective paper questionnaire. Change from baseline to 90 days and to 180 days is calculated as the value at 90/180 days minus the value at baseline. Negative values for change from baseline to follow-up indicate reduction (improvement) in nasal obstruction/congestion.	Baseline, 90 days, 180 days

Collaborators and Investigators

• Sponsor: Intersect ENT
• Investigators: Principal Investigator: Peter Manes, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): January 17, 2019
• Study Completion (Actual): January 17, 2019

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: corticosteroid; implant
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Polyps; Sinusitis; Chronic Disease; Nasal Polyps
• Other Study ID Numbers: P500-0717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No