Trial Outcomes & Findings for Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia (NCT NCT02228720)

Results Overview

Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline Procedure

Results posted on

2017-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	Propel Nova Sinus Implant Sinus stent with steroid coating (370 ug mometasone furoate) Propel Nova Sinus Implant: Sinus stent with steroid coating (370 ug mometasone furoate)
Open Label - Baseline STARTED	15
Open Label - Baseline COMPLETED	15
Open Label - Baseline NOT COMPLETED	0
Open Label - Day 30 STARTED	15
Open Label - Day 30 COMPLETED	14
Open Label - Day 30 NOT COMPLETED	1
Open Label - Day 90 STARTED	14
Open Label - Day 90 COMPLETED	14
Open Label - Day 90 NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Propel Nova Sinus Implant Sinus stent with steroid coating (370 ug mometasone furoate) Propel Nova Sinus Implant: Sinus stent with steroid coating (370 ug mometasone furoate)
Open Label - Day 30 Lost to Follow-up	1

Baseline Characteristics

Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propel Nova Sinus Implant n=15 Participants Steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
Age, Continuous	50.6 years STANDARD_DEVIATION 13.24 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Lund-Mackay Score (CT scan) Frontal Sinuses	2.5 units on a scale STANDARD_DEVIATION 1.19 • n=93 Participants
Lund-Mackay Score (CT scan) Maxillary Sinuses	2.3 units on a scale STANDARD_DEVIATION 0.98 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline Procedure

Population: Attempted frontal and maxillary sinus ostia

Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.

Outcome measures

Outcome measures
Measure	Propel Nova Sinus Implant n=45 Sinuses Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Device Placement Success Rate Frontal Sinuses	100 Percentage of attempted sinuses
Device Placement Success Rate Maxillary Sinuses	95.2 Percentage of attempted sinuses

SECONDARY outcome

Timeframe: Baseline, Day 30, Day 90

Population: Frontal and maxillary sinus ostia

Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)

Outcome measures

Outcome measures
Measure	Propel Nova Sinus Implant n=45 Sinuses Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Ostial Patency Baseline - Frontal Sinuses	33.3 percentage of evaluable sinuses
Ostial Patency Day 30 - Frontal Sinuses	100 percentage of evaluable sinuses
Ostial Patency Day 90 - Frontal Sinuses	88.2 percentage of evaluable sinuses
Ostial Patency Baseline - Maxillary Sinuses	57.1 percentage of evaluable sinuses
Ostial Patency Day 30 - Maxillary Sinuses	100 percentage of evaluable sinuses
Ostial Patency Day 90 - Maxillary Sinuses	94.1 percentage of evaluable sinuses

SECONDARY outcome

Timeframe: Baseline, Day 30, Day 90

Population: Frontal and maxillary sinus ostia

Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)

Outcome measures

Outcome measures
Measure	Propel Nova Sinus Implant n=45 Sinuses Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Adhesion/Scarring Grade 2 & 3 Baseline - Frontal Sinuses	33.4 percentage of evaluable sinuses
Adhesion/Scarring Grade 2 & 3 Day 30 - Frontal Sinuses	4.5 percentage of evaluable sinuses
Adhesion/Scarring Grade 2 & 3 Day 90 - Frontal Sinuses	11.8 percentage of evaluable sinuses
Adhesion/Scarring Grade 2 & 3 Baseline - Maxillary Sinuses	19.1 percentage of evaluable sinuses
Adhesion/Scarring Grade 2 & 3 Day 30 - Maxillary Sinuses	0 percentage of evaluable sinuses
Adhesion/Scarring Grade 2 & 3 Day 90 - Maxillary Sinuses	5.3 percentage of evaluable sinuses

SECONDARY outcome

Timeframe: Baseline, Day 30, Day 90

Population: Frontal and maxillary sinus ostia

Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)

Outcome measures

Outcome measures
Measure	Propel Nova Sinus Implant n=45 Sinuses Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Degree of Inflammation Baseline - Frontal Sinuses	62.8 units on a scale Standard Deviation 23.14
Degree of Inflammation Day 30 - Frontal Sinuses	28.1 units on a scale Standard Deviation 23.24
Degree of Inflammation Day 90 - Frontal Sinuses	25.0 units on a scale Standard Deviation 25.23
Degree of Inflammation Baseline - Maxillary Sinuses	51.6 units on a scale Standard Deviation 24.94
Degree of Inflammation Day 30 - Maxillary Sinuses	22.2 units on a scale Standard Deviation 13.55
Degree of Inflammation Day 90 - Maxillary Sinuses	14.1 units on a scale Standard Deviation 21.6

SECONDARY outcome

Timeframe: Baseline, Day 30, Day 90

Population: Adult patients (≥ 18 years of age) diagnosed with chronic sinusitis with or without nasal/sinus polyposis who are candidates for endoscopic sinus surgery and in whom placement of the Propel Nova Sinus Implant is both feasible and medically appropriate

Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110

Outcome measures

Outcome measures
Measure	Propel Nova Sinus Implant n=15 Participants Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Sino-Nasal Outcome Test (SNOT) 22 Baseline	42.6 units on a scale Standard Deviation 14.9
Sino-Nasal Outcome Test (SNOT) 22 Day 30	21.5 units on a scale Standard Deviation 19.0
Sino-Nasal Outcome Test (SNOT) 22 Day 90	20.6 units on a scale Standard Deviation 19.3

Adverse Events

Propel Nova Sinus Implant

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Propel Nova Sinus Implant n=15 participants at risk Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	6.7% 1/15 • Number of events 1 • Day 90

Other adverse events

Other adverse events
Measure	Propel Nova Sinus Implant n=15 participants at risk Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time
Infections and infestations Acute Sinusitis	6.7% 1/15 • Number of events 1 • Day 90
Respiratory, thoracic and mediastinal disorders Bronchitis	6.7% 1/15 • Number of events 1 • Day 90
Respiratory, thoracic and mediastinal disorders Chronic Sinusitis	6.7% 1/15 • Number of events 1 • Day 90
Respiratory, thoracic and mediastinal disorders Nasal Congestion	20.0% 3/15 • Number of events 3 • Day 90
Respiratory, thoracic and mediastinal disorders Nasal polyps	6.7% 1/15 • Number of events 1 • Day 90
Infections and infestations Upper Respiratory Infection	6.7% 1/15 • Number of events 1 • Day 90
General disorders Vasovagal Reaction	6.7% 1/15 • Number of events 1 • Day 90
Respiratory, thoracic and mediastinal disorders Sinus Drainage, green	6.7% 1/15 • Number of events 1 • Day 90
Respiratory, thoracic and mediastinal disorders Crusting in nares	6.7% 1/15 • Number of events 1 • Day 90

Additional Information

James Stambaugh

Intersect ENT

Phone: 6506412103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place