Chronic SinusitisPhase 3NCT03358329
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)
A Phase 3 study testing S8 Sinus Implant in people with Chronic Sinusitis and Nasal Polyposis, run by Intersect ENT at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis, Nasal Polyposis
- What is being tested?
- S8 Sinus Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesUnited States
- Study dates
- 13 Nov 2017to 17 Jan 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
- Patient has known dehiscence of the lamina papyracea.
- Patient has evidence of active tuberculosis or active viral illness (e.g., ocular herpes simplex, chickenpox, measles).
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
BreatheAmerica of Albuquerque
Albuquerque, New Mexico, 87109
Charlotte Eye, Ear, Nose and Throat Associates
Concord, North Carolina, 29025
Associated Surgical Specialists
Covington, Louisiana, 70433
Advanced ENT & Allergy
Louisville, Kentucky, 40207
DuPage Medical Group
Naperville, Illinois, 60540
Yale University School of Medicine
New Haven, Connecticut, 06519
Madison ENT
New York, New York, 10016
Bridgerland Clinical Research
North Logan, Utah, 84341
Sacramento ENT
Sacramento, California, 95815
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Sinusitis, Nasal Polyposis
- Being tested
- S8 Sinus Implant
- Keywords
- corticosteroid, implant
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S8 Sinus ImplantCombination product
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
| Study group | Role | What they receive |
|---|---|---|
| S8 Sinus Implant | Experimental | corticosteroid-eluting sinus implant containing 1350 mcg of mometasone furoate (MF) Receives: Combination Product: S8 Sinus Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 365 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 90 days, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start13 Nov 2017
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersect ENT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Manes, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358329
- Sponsor's protocol ID
- P500-0717
- Status last verified
- Nov 2019
- First submitted
- 27 Nov 2017
- Last updated
- 27 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ENCORE Study: Safety Evaluation of Repeat Placement of the Corticosteroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps
- ClinicalTrials.gov ID
- NCT03358329
- Acronym / sponsor ID
- P500-0717
- Conditions
- Chronic Sinusitis, Nasal Polyposis
- Keywords
- corticosteroid, implant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Intersect ENTIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S8 Sinus Implant | Experimental | Combination Product: S8 Sinus Implantcorticosteroid-eluting sinus implant containing 1350 mcg of mometasone furoate (MF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S8 Sinus ImplantIn-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses | Combination product | S8 Sinus Implant |
Primary outcome
Number of Participants With Implant-Related Serious Adverse Events
Time frame: 365 days
Evaluated via tabulation of implant-related serious adverse events (SAE) reported by subjects between consent and Day 365.
2 secondary outcomes
SNOT-22 Total Score
Time frame: Baseline, 90 days, 180 days
Nasal Obstruction/Congestion Score
Time frame: Baseline, 90 days, 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Manes, MD principal investigator
Yale University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S8 Sinus Implant in people with Chronic Sinusitis and Nasal Polyposis, run by Intersect ENT at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Implant-Related Serious Adverse Events (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.