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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358329
• Other study ID #: P500-0717
• Status: Completed
• Phase: Phase 3
• Start date: November 13, 2017
• Est. completion date: January 17, 2019

Study information

• Verified date: November 2019
• Source: Intersect ENT
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Nasal Polyposis
• Nasal Polyps
• Sinusitis

Intervention

Combination Product:
• S8 Sinus Implant
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Locations

Country	Name	City	State
United States	BreatheAmerica of Albuquerque	Albuquerque	New Mexico
United States	Charlotte Eye, Ear, Nose and Throat Associates	Concord	North Carolina
United States	Associated Surgical Specialists	Covington	Louisiana
United States	Advanced ENT & Allergy	Louisville	Kentucky
United States	DuPage Medical Group	Naperville	Illinois
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Madison ENT	New York	New York
United States	Bridgerland Clinical Research	North Logan	Utah
United States	Sacramento ENT	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Intersect ENT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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