Trial Outcomes & Findings for Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus (NCT NCT02266810)

NCT ID: NCT02266810

Last Updated: 2018-08-15

Results Overview

The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 160 participants
• Primary outcome timeframe: Day 30
• Results posted on: 2018-08-15

Participant Flow

Unit of analysis: sinus sides

Participant milestones

Measure	PROPEL Mini Sinus Implant This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned. PROPEL Mini Sinus Implant: Placement of sinus implant following frontal sinus surgery	PROPEL Nova Sinus Implant This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned. PROPEL Nova Sinus Implant: Placement of sinus implant following frontal sinus surgery
Overall Study STARTED	80 160	80 160
Overall Study COMPLETED	79 158	79 158
Overall Study NOT COMPLETED	1 2	1 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus

Baseline characteristics by cohort

Measure	PROPEL Mini Sinus Implant and No Implant Cohort 1 n=80 Participants This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned. PROPEL Mini or Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery	PROPEL Nova Sinus Implant and No Implant Cohort 2 n=80 Participants This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned. PROPEL Mini or Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Total n=160 Participants Total of all reporting groups
Age, Continuous	49.9 years STANDARD_DEVIATION 13.91 • n=5 Participants	49.5 years STANDARD_DEVIATION 13.36 • n=7 Participants	49.7 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	27 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	53 Participants n=7 Participants	99 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants	77 Participants n=7 Participants	157 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	68 Participants n=7 Participants	130 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants	80 participants n=7 Participants	160 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: ITT population

The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.

Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).

Outcome measures

Measure	PROPEL Mini Sinus Implant n=67 Participants Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Sinus Surgery Only: Cohort 1 n=67 Participants Sinus surgery with standard post-operative care. Sinus Surgery alone: Sinus surgery only, without implant placement
Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)	38.8 percent sinuses requiring intervention Interval 27.1 to 51.5	62.7 percent sinuses requiring intervention Interval 50.0 to 74.2

PRIMARY outcome

Timeframe: Day 30

Population: Of the 80 patients who had their endoscopy recorded at day 30 for grading by independent reviewer; 19 patients could not be included in the test due to missing data. Data were considered missing if the independent reviewer could not grade a video on one or both treatment sinus sides.

The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.

Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).

Outcome measures

Measure	PROPEL Mini Sinus Implant n=61 Participants Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Sinus Surgery Only: Cohort 1 n=61 Participants Sinus surgery with standard post-operative care. Sinus Surgery alone: Sinus surgery only, without implant placement
Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)	11.5 percentage sinus requiring intervention Interval 4.7 to 22.2	32.8 percentage sinus requiring intervention Interval 21.3 to 46.0

SECONDARY outcome

Timeframe: Day 30

Need for post-operative interventions by clinical investigators at Day 30

Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).

Outcome measures

Measure	PROPEL Mini Sinus Implant n=79 sinus sides Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Sinus Surgery Only: Cohort 1 n=79 sinus sides Sinus surgery with standard post-operative care. Sinus Surgery alone: Sinus surgery only, without implant placement
Need for Post-operative Interventions (Propel Mini Cohort)	16.5 percentage of evaluable sinuses Interval 9.1 to 26.5	41.8 percentage of evaluable sinuses Interval 30.8 to 53.4

SECONDARY outcome

Timeframe: Day 30

Need for Surgical Interventions by clinical investigators at Day 30.

Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.

Adhesions/Scarring was assessed based on a 4-point scale as follows:

0= No visible granulation/scarring in the FSO

1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)

2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)

3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)

Outcome measures

Measure	PROPEL Mini Sinus Implant n=75 sinus sides Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Sinus Surgery Only: Cohort 1 n=75 sinus sides Sinus surgery with standard post-operative care. Sinus Surgery alone: Sinus surgery only, without implant placement
Need for Surgical Interventions (Propel Mini Cohort)	4.0 percentage of evaluable sinuses	16.0 percentage of evaluable sinuses

SECONDARY outcome

Timeframe: Day 30

The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.

Outcome measures

Measure	PROPEL Mini Sinus Implant n=79 sinus sides Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Sinus Surgery Only: Cohort 1 n=79 sinus sides Sinus surgery with standard post-operative care. Sinus Surgery alone: Sinus surgery only, without implant placement
Inflammation (Propel Mini Cohort)	24.7 100-mm VAS Standard Deviation 27.02	41.3 100-mm VAS Standard Deviation 29.34

SECONDARY outcome

Timeframe: Day 30

Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:

0=Patent

1. Restenosed/Partially Occluded

2. Occluded

Outcome measures

Measure	PROPEL Mini Sinus Implant n=76 sinus sides Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Sinus Surgery Only: Cohort 1 n=76 sinus sides Sinus surgery with standard post-operative care. Sinus Surgery alone: Sinus surgery only, without implant placement
Occlusion/Restenosis (Propel Mini Cohort)	21.1 percentage of evaluable sinuses Interval 12.5 to 31.9	46.1 percentage of evaluable sinuses Interval 34.5 to 57.9

SECONDARY outcome

Timeframe: Day 30

Need for post-operative interventions by clinical investigators at Day 30.

Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).

Outcome measures

Measure	PROPEL Mini Sinus Implant n=75 sinus sides Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Sinus Surgery Only: Cohort 1 n=75 sinus sides Sinus surgery with standard post-operative care. Sinus Surgery alone: Sinus surgery only, without implant placement
Need for Post-operative Interventions (Propel Nova Cohort)	16.0 percentage of evaluable sinuses Interval 8.6 to 26.3	33.3 percentage of evaluable sinuses Interval 22.9 to 45.2

SECONDARY outcome

Timeframe: Day 30

Need for Surgical Interventions by clinical investigators at Day 30

Need for Surgical Interventions by clinical investigators at Day 30.

Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.

Adhesions/Scarring was assessed based on a 4-point scale as follows:

0= No visible granulation/scarring in the FSO

1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)

2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)

3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)

Outcome measures

Measure	PROPEL Mini Sinus Implant n=75 sinus sides Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Sinus Surgery Only: Cohort 1 n=75 sinus sides Sinus surgery with standard post-operative care. Sinus Surgery alone: Sinus surgery only, without implant placement
Need for Surgical Interventions (Propel Nova Cohort)	4.0 percentage of evaluable sinuses	14.7 percentage of evaluable sinuses

SECONDARY outcome

Timeframe: Day 30

The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.

Outcome measures

Measure	PROPEL Mini Sinus Implant n=79 sinus sides Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Sinus Surgery Only: Cohort 1 n=77 sinus sides Sinus surgery with standard post-operative care. Sinus Surgery alone: Sinus surgery only, without implant placement
Inflammation (Propel Nova Cohort)	23.1 100-mm VAS Standard Deviation 24.23	35.6 100-mm VAS Standard Deviation 31.12

SECONDARY outcome

Timeframe: Day 30

Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:

0=Patent

1. Restenosed/Partially Occluded

2. Occluded

Outcome measures

Measure	PROPEL Mini Sinus Implant n=75 sinus sides Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	Sinus Surgery Only: Cohort 1 n=75 sinus sides Sinus surgery with standard post-operative care. Sinus Surgery alone: Sinus surgery only, without implant placement
Occlusion/Restenosis (Propel Nova Cohort)	13.3 percentage of evaluable sinuses Interval 6.6 to 23.2	36.0 percentage of evaluable sinuses Interval 25.2 to 47.9

Adverse Events

PROPEL Mini Sinus Implant

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

PROPEL Nova Sinus Implant

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	PROPEL Mini Sinus Implant n=80 participants at risk Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	PROPEL Nova Sinus Implant n=80 participants at risk Propel Nova placed in frontal sinus opening following ESS PROPEL Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery
Vascular disorders Cerebrovascular Accident	0.00% 0/80 • Propel Mini cohort: 90 days	1.2% 1/80 • Number of events 1 • Propel Mini cohort: 90 days
Infections and infestations Diverticulitis	1.2% 1/80 • Number of events 1 • Propel Mini cohort: 90 days	0.00% 0/80 • Propel Mini cohort: 90 days
Infections and infestations Respiratory tract infection fungal	1.2% 1/80 • Number of events 1 • Propel Mini cohort: 90 days	0.00% 0/80 • Propel Mini cohort: 90 days
Vascular disorders deep vein thrombosis	1.2% 1/80 • Number of events 2 • Propel Mini cohort: 90 days	0.00% 0/80 • Propel Mini cohort: 90 days

Other adverse events

Measure	PROPEL Mini Sinus Implant n=80 participants at risk Propel Mini placed in frontal sinus opening following ESS PROPEL Mini Sinus Implant.: Placement of sinus implant following frontal sinus surgery	PROPEL Nova Sinus Implant n=80 participants at risk Propel Nova placed in frontal sinus opening following ESS PROPEL Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery
Infections and infestations acute sinusitis	15.0% 12/80 • Number of events 12 • Propel Mini cohort: 90 days	20.0% 16/80 • Number of events 16 • Propel Mini cohort: 90 days
Infections and infestations chronic sinusitis	11.2% 9/80 • Number of events 9 • Propel Mini cohort: 90 days	5.0% 4/80 • Number of events 4 • Propel Mini cohort: 90 days
Infections and infestations upper respiratory tract infection	6.2% 5/80 • Number of events 5 • Propel Mini cohort: 90 days	5.0% 4/80 • Number of events 4 • Propel Mini cohort: 90 days
Nervous system disorders headache	11.2% 9/80 • Number of events 9 • Propel Mini cohort: 90 days	6.2% 5/80 • Number of events 5 • Propel Mini cohort: 90 days
Nervous system disorders presyncope	5.0% 4/80 • Number of events 4 • Propel Mini cohort: 90 days	0.00% 0/80 • Propel Mini cohort: 90 days
Respiratory, thoracic and mediastinal disorders epistaxis	5.0% 4/80 • Number of events 4 • Propel Mini cohort: 90 days	1.2% 1/80 • Number of events 1 • Propel Mini cohort: 90 days
Respiratory, thoracic and mediastinal disorders asthma	0.00% 0/80 • Propel Mini cohort: 90 days	7.5% 6/80 • Number of events 6 • Propel Mini cohort: 90 days

Additional Information

James Stambaugh (VP, Clinical Affairs)

Intersect ENT

Phone: 650-641-2103

Email: jstambaugh@intersectent.com

Results disclosure agreements

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

Restriction type: LTE60