NCT03358329

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

Completed Phase 3 Results posted Last updated 27 November 2019

What this trial tests

Phase 3 trial testing S8 Sinus Implant in Chronic Sinusitis in 50 participants. Completed in 17 January 2019.

Timeline

13 November 2017

Primary endpoint
17 January 2019

17 January 2019

Quick facts

Lead sponsor	Intersect ENT
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	13 November 2017
Primary completion	17 January 2019
Estimated completion	17 January 2019
Sites	9 locations across United States

Drugs / interventions tested

• S8 Sinus Implant — full drug profile →

Conditions studied

• Chronic Sinusitis — all drugs for Chronic Sinusitis →
• Nasal Polyposis — all drugs for Nasal Polyposis →

Sponsor

Intersect ENT — full company profile →

Who can join

18 and older, any sex, with Chronic Sinusitis or Nasal Polyposis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Implant-Related Serious Adverse Events Primary · 365 days

Evaluated via tabulation of implant-related serious adverse events (SAE) reported by subjects between consent and Day 365.

Group	Value	95% CI
S8 Sinus Implant	0

SNOT-22 Total Score Secondary · Baseline, 90 days, 180 days

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.

Change from baseline to Day 90

Group	Value	95% CI
S8 Sinus Implant	-14.9	± 19.27

Change from baseline to Day 180

Group	Value	95% CI
S8 Sinus Implant	-15.4	± 20.36

Nasal Obstruction/Congestion Score Secondary · Baseline, 90 days, 180 days

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.

Change from baseline to Day 90

Group	Value	95% CI
S8 Sinus Implant	-0.6	± 0.91

Change from baseline to Day 180

Group	Value	95% CI
S8 Sinus Implant	-0.6	± 0.94

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from enrollment through Day 365.. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

S8 Sinus Implant

Serious: 4/50 (8%)

Deaths: 0/50

Serious adverse events (5 terms)

Reaction	System	S8 Sinus Implant
brain hypoxia	Nervous system disorders	—
cardiac arrest	Cardiac disorders	—
renal failure	Renal and urinary disorders	—
small intestine obstruction	Gastrointestinal disorders	—
pneumonia	Infections and infestations	—

Other adverse events (4 terms — click to expand)

Reaction	System	S8 Sinus Implant
epistaxis	Respiratory, thoracic and mediastinal disorders	—
nasal discomfort	Respiratory, thoracic and mediastinal disorders	—
rhinalgia	Respiratory, thoracic and mediastinal disorders	—
acute sinusitis	Infections and infestations	—

Most-reported serious reactions: brain hypoxia, cardiac arrest, renal failure, small intestine obstruction, pneumonia.

Data from ClinicalTrials.gov NCT03358329 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. In-office Placement of Mometasone Furoate Sinus Implants for Recurrent Nasal Polyps: A Pooled Analysis.
   Stolovitzky JP, Kern RC, Han JK, Forwith KD, et al · · 2019 · cited 12× · PMID 31117809 · DOI 10.1177/1945892419850924