Trial Outcomes & Findings for Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) (NCT NCT03358329)

NCT ID: NCT03358329

Last Updated: 2019-11-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 50 participants
• Primary outcome timeframe: 365 days
• Results posted on: 2019-11-27

Participant Flow

Patients were recruited at 10 sites across the US between November 2017 and January 2018.

Participant milestones

Measure	S8 Sinus Implant Corticosteroid-eluting Sinus Implant with 1350 mcg of MF Mometasone furoate nasal spray (200 mcg) once daily
Overall Study STARTED	50
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	S8 Sinus Implant Corticosteroid-eluting Sinus Implant with 1350 mcg of MF Mometasone furoate nasal spray (200 mcg) once daily
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	S8 Sinus Implant n=50 Participants Corticosteroid-eluting Sinus Implant with 1350 mcg of MF Mometasone furoate nasal spray (200 mcg) once daily
Age, Continuous	53.2 years STANDARD_DEVIATION 12.73 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Race/Ethnicity, Customized White	46 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
SNOT-22	41.5 units on a scale STANDARD_DEVIATION 20.84 • n=5 Participants
Nasal Obstruction/Congestion ≥ 2	38 Participants n=5 Participants
Ethmoid Sinus Obstruction	73.2 percent of obstruction STANDARD_DEVIATION 22.89 • n=5 Participants

PRIMARY outcome

Timeframe: 365 days

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

Outcome measures

Measure	S8 Sinus Implant n=50 Participants Corticosteroid-eluting Sinus Implant with 1350 mcg of MF Mometasone furoate nasal spray (MFNS, 200 mcg) once daily
Number of Participants With Implant-Related Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Baseline, 90 days, 180 days

Population: Analysis population includes subjects with available data at that time point.

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.

Outcome measures

Measure	S8 Sinus Implant n=50 Participants Corticosteroid-eluting Sinus Implant with 1350 mcg of MF Mometasone furoate nasal spray (MFNS, 200 mcg) once daily
SNOT-22 Total Score Change from baseline to Day 90	-14.9 score on a scale Standard Deviation 19.27
SNOT-22 Total Score Change from baseline to Day 180	-15.4 score on a scale Standard Deviation 20.36

SECONDARY outcome

Timeframe: Baseline, 90 days, 180 days

Population: Analysis population includes subjects with available data at that time point.

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.

Outcome measures

Measure	S8 Sinus Implant n=50 Participants Corticosteroid-eluting Sinus Implant with 1350 mcg of MF Mometasone furoate nasal spray (MFNS, 200 mcg) once daily
Nasal Obstruction/Congestion Score Change from baseline to Day 90	-0.6 units on a scale Standard Deviation 0.91
Nasal Obstruction/Congestion Score Change from baseline to Day 180	-0.6 units on a scale Standard Deviation 0.94

Adverse Events

S8 Sinus Implant

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	S8 Sinus Implant n=50 participants at risk Corticosteroid-eluting Sinus Implant with1350 mcg MF. MFNS (200 mcg) once daily
Nervous system disorders brain hypoxia	2.0% 1/50 • Number of events 1 • Adverse events were collected from enrollment through Day 365.
Cardiac disorders cardiac arrest	2.0% 1/50 • Number of events 1 • Adverse events were collected from enrollment through Day 365.
Renal and urinary disorders renal failure	2.0% 1/50 • Number of events 1 • Adverse events were collected from enrollment through Day 365.
Gastrointestinal disorders small intestine obstruction	2.0% 1/50 • Number of events 1 • Adverse events were collected from enrollment through Day 365.
Infections and infestations pneumonia	2.0% 1/50 • Number of events 1 • Adverse events were collected from enrollment through Day 365.

Other adverse events

Measure	S8 Sinus Implant n=50 participants at risk Corticosteroid-eluting Sinus Implant with1350 mcg MF. MFNS (200 mcg) once daily
Infections and infestations acute sinusitis	4.0% 2/50 • Number of events 2 • Adverse events were collected from enrollment through Day 365.
Respiratory, thoracic and mediastinal disorders epistaxis	6.0% 3/50 • Number of events 3 • Adverse events were collected from enrollment through Day 365.
Respiratory, thoracic and mediastinal disorders nasal discomfort	6.0% 3/50 • Number of events 3 • Adverse events were collected from enrollment through Day 365.
Respiratory, thoracic and mediastinal disorders rhinalgia	6.0% 3/50 • Number of events 3 • Adverse events were collected from enrollment through Day 365.

Additional Information

James Stambaugh, Vice President of Clinical & Medical Affairs

Intersect ENT, Inc.

Phone: 650-641-2103

Email: jstambaugh@intersectent.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place