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

NCT03358329 | Completed Phase 3 Results FDA Drug

• 1 other identifier: P500-0717
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Chronic Sinusitis; Nasal Polyposis

Keywords

corticosteroid; implant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• SNOT-22 Total Score

  Baseline, 90 days, 180 days

• Nasal Obstruction/Congestion Score

  Baseline, 90 days, 180 days

Study Arms (1)

S8 Sinus Implant

EXPERIMENTAL

corticosteroid-eluting sinus implant containing 1350 mcg of mometasone furoate (MF)

Combination Product: S8 Sinus Implant

Interventions

S8 Sinus Implant COMBINATION_PRODUCT

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

S8 Sinus Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has provided written informed consent using a form approved by the reviewing institutional review board (IRB) and sponsor.
• Patient is ≥ 18 years of age.
• Patient is willing and able to comply with protocol requirements.
• Patient has a confirmed diagnosis of CS with nasal polyps, as defined in the 2016 "International Consensus Statement on Allergy and Rhinology".
• Patient has undergone prior ESS including bilateral total ethmoidectomy at least 90 days prior to screening.
• Patient has evidence of bilateral ethmoid sinus obstruction due to polyposis warranting intervention (polyp grade ≥ 2 on each side).
• Patient is able to tolerate daily use of Mometasone Furoate Nasal Spray (MFNS).
• Patient is able to tolerate topical/local anesthesia.
• 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).
• Female patients of reproductive potential must not be pregnant or nursing and must agree to not become pregnant during their participation in the study.
• Female patients of childbearing potential must agree to use consistent and acceptable method(s) of birth control during their participation in the study.

You may not qualify if:

• Patient has extensive ethmoid sinus polyp grade (grade 4 on at least one side).
• Patient has extensive adhesions/synechiae (grade 3 or 4).
• Patient has used parenteral and injected steroids (e.g., Kenalog injection) during 30 days prior to the baseline procedure.
• 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.
• Patient has oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or asthma.
• Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate.
• Patient has used monoclonal antibodies for asthma, allergies or nasal polyps (e.g., Dupixent, Nucala, Xolair) during 30 days prior to the baseline procedure.
• Patient requires monoclonal antibodies for asthma, allergies or nasal polyps during the duration of the study.
• 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).
• Patient has known history of human immunodeficiency virus (HIV) or immunoglobulin G or A subclass deficiency.
• Patient has clinical evidence of acute sinusitis (AS), as defined in the 2016 "International Consensus Statement on Allergy and Rhinology".
• Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on prior computed tomography (CT) scan, necrotic sinus tissue).
• 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).
• Patient is currently participating in another clinical study.
• 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.

Sponsors & Collaborators

• Intersect ENT: lead

Study Sites (9)

Sacramento ENT

Sacramento, California, 95815, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

DuPage Medical Group

Naperville, Illinois, 60540, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40207, United States

Location

Associated Surgical Specialists

Covington, Louisiana, 70433, United States

Location

BreatheAmerica of Albuquerque

Albuquerque, New Mexico, 87109, United States

Location

Madison ENT

New York, New York, 10016, United States

Location

Charlotte Eye, Ear, Nose and Throat Associates

Concord, North Carolina, 29025, United States

Location

Bridgerland Clinical Research

North Logan, Utah, 84341, United States

Location

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: James Stambaugh, Vice President of Clinical & Medical Affairs
• Organization: Intersect ENT, Inc.

jstambaugh@intersectent.com

650-641-2103

Study Officials

• Peter Manes, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: November 30, 2017
• Study Start: November 13, 2017
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)