Trial Outcomes & Findings for A Clinical Evaluation of PROPEL® Contour Sinus Implant (NCT NCT04858802)

NCT ID: NCT04858802

Last Updated: 2023-04-21

Results Overview

Side-to-side difference in frontal sinus ostium (FSO) patency at Day 45 based on cross-sectional area of FSO by computed tomography (CT) measurements performed by an independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Day 45
• Results posted on: 2023-04-21

Participant Flow

Participants were recruited from fourteen locations in the United States.

A total of 89 patients were assessed for eligibility. Eight patients did not meet inclusion criteria or met exclusion criteria. One patient withdrew from the study prior to randomization. A total of 80 patients met final eligibility and were randomized.

Unit of analysis: sinus sides

Participant milestones

Measure	PROPEL Contour Sinus Implant Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant	Balloon Sinus Dilation Alone Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant
Overall Study STARTED	80 80	80 80
Overall Study Completed Day 45 Follow-up Visit	80 80	80 80
Overall Study COMPLETED	78 78	78 78
Overall Study NOT COMPLETED	2 2	2 2

Reasons for withdrawal

Measure	PROPEL Contour Sinus Implant Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant	Balloon Sinus Dilation Alone Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

A Clinical Evaluation of PROPEL® Contour Sinus Implant

Baseline characteristics by cohort

Measure	All Participants n=80 Participants Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the frontal sinus ostium occurred on the randomized side. The opposing side served as control. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
Age, Continuous	52.5 years STANDARD_DEVIATION 13.38 • n=5 Participants
Sex/Gender, Customized Female	30 participants n=5 Participants
Sex/Gender, Customized Male	50 participants n=5 Participants
Race/Ethnicity, Customized White	69 participants n=5 Participants
Race/Ethnicity, Customized Asian	7 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants
Number of prior endoscopic sinus surgeries (ESS) 0	36 participants n=5 Participants
Number of prior endoscopic sinus surgeries (ESS) 1	26 participants n=5 Participants
Number of prior endoscopic sinus surgeries (ESS) 2	12 participants n=5 Participants
Number of prior endoscopic sinus surgeries (ESS) 3	4 participants n=5 Participants
Number of prior endoscopic sinus surgeries (ESS) ≥ 4	2 participants n=5 Participants
Asthma diagnosed by physician Yes, any severity	15 participants n=5 Participants
Asthma diagnosed by physician Yes, mild	13 participants n=5 Participants
Asthma diagnosed by physician Yes, moderate	2 participants n=5 Participants
Asthma diagnosed by physician Yes, severe	0 participants n=5 Participants
Allergic rhinitis diagnosed by physician Yes, any severity	68 participants n=5 Participants
Allergic rhinitis diagnosed by physician Yes, mild	39 participants n=5 Participants
Allergic rhinitis diagnosed by physician Yes, moderate	27 participants n=5 Participants
Allergic rhinitis diagnosed by physician Yes, severe	2 participants n=5 Participants
Aspirin intolerance or allergy	2 participants n=5 Participants
Lund-Mackay score Total score (left + right)	9.21 units on a scale STANDARD_DEVIATION 3.83 • n=5 Participants
Lund-Mackay score Frontal sinus score (left + right)	2.19 units on a scale STANDARD_DEVIATION 0.48 • n=5 Participants

PRIMARY outcome

Timeframe: Day 45

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable.

Side-to-side difference in frontal sinus ostium (FSO) patency at Day 45 based on cross-sectional area of FSO by computed tomography (CT) measurements performed by an independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=76 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=76 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
Difference in FSO Patency by Blinded Reviewer	12.36 mm^2 Standard Deviation 16.10	16.54 mm^2 Standard Deviation 20.83

SECONDARY outcome

Timeframe: Baseline, Day 45, and Day 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer. FSO cross-sectional area was measured via computer-assisted segmentation of CT images.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=75 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=75 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer Change from baseline to Day 45	1.15 mm^2 Standard Deviation 11.09	2.63 mm^2 Standard Deviation 9.95
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer Change from baseline to Day 180	5.95 mm^2 Standard Deviation 13.78	3.20 mm^2 Standard Deviation 10.97

SECONDARY outcome

Timeframe: Days 45 and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, is assessed by blinded reviewer. FSOT volume was measured via computer-assisted segmentation of CT images.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=76 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=76 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer Day 45	332.17 mm^3 Standard Deviation 399.68	383.11 mm^3 Standard Deviation 437.19
CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer Day 180	414.30 mm^3 Standard Deviation 427.56	386.86 mm^3 Standard Deviation 413.56

SECONDARY outcome

Timeframe: Days 45 and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

CT FSO minimum diameter assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. FSO minimum diameter was measured via computer-assisted segmentation of CT images.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=76 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=76 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
CT FSO Minimum Diameter by Blinded Reviewer Day 45	1.89 mm Standard Deviation 1.79	2.38 mm Standard Deviation 1.94
CT FSO Minimum Diameter by Blinded Reviewer Day 180	2.54 mm Standard Deviation 2.13	2.56 mm Standard Deviation 2.23

SECONDARY outcome

Timeframe: Days 45 and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

CT Zinreich's modified Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.

Zinreich's modified Lund-Mackay scale ranges from 0 to 5. Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=78 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=78 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer Day 45	1.28 score on a scale Standard Deviation 1.38	1.23 score on a scale Standard Deviation 1.22
CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer Day 180	1.05 score on a scale Standard Deviation 1.27	1.22 score on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: Days 21, 45, 90 and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

Need for post-operative intervention as determined by clinical investigators per endoscopy.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=80 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=80 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators Day 21	5 sinus sides	5 sinus sides
Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators Day 45	17 sinus sides	14 sinus sides
Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators Day 90	16 sinus sides	12 sinus sides
Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators Day 180	16 sinus sides	12 sinus sides

SECONDARY outcome

Timeframe: Day 180

CT cross-sectional area of FSO assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=75 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=75 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
CT Cross-sectional Area of FSO by Blinded Reviewer	17.81 mm^2 Standard Deviation 19.96	17.72 mm^2 Standard Deviation 21.05

SECONDARY outcome

Timeframe: Days 45 and 180

CT Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.

The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=78 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=78 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer Day 45	0.77 score on a scale Standard Deviation 0.56	0.77 score on a scale Standard Deviation 0.48
CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer Day 180	0.67 score on a scale Standard Deviation 0.55	0.72 score on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: Days 45 and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

CT Lund-Mackay for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.

The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=79 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=79 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators Day 45	0.68 score on a scale Standard Deviation 0.59	0.59 score on a scale Standard Deviation 0.59
CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators Day 180	0.59 score on a scale Standard Deviation 0.63	0.53 score on a scale Standard Deviation 0.64

SECONDARY outcome

Timeframe: Days 21, 45, 90 and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

Endoscopic grading of adhesion/scarring grade in the frontal recess/FSO by clinical investigators.

The adhesion/scarring grade in the frontal recess/FSO scale ranges from 0 to 4. Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=75 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=76 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators Day 21	0.41 score on a scale Standard Deviation 0.61	0.37 score on a scale Standard Deviation 0.63
Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators Day 45	0.48 score on a scale Standard Deviation 0.75	0.30 score on a scale Standard Deviation 0.62
Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators Day 90	0.48 score on a scale Standard Deviation 0.78	0.21 score on a scale Standard Deviation 0.54
Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators Day 180	0.45 score on a scale Standard Deviation 0.74	0.24 score on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: Days 21, 45, 90 and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

Endoscopic grading of inflammation score in the frontal recess/FSO by clinical investigators.

Inflammation score in the frontal recess/FSO ranges from 0 to 100. Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=74 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=76 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
Inflammation Score in the Frontal Recess/FSO by Clinical Investigators Day 21	28.85 score on a scale Standard Deviation 30.86	25.94 score on a scale Standard Deviation 29.31
Inflammation Score in the Frontal Recess/FSO by Clinical Investigators Day 45	26.67 score on a scale Standard Deviation 32.16	19.17 score on a scale Standard Deviation 27.68
Inflammation Score in the Frontal Recess/FSO by Clinical Investigators Day 90	28.62 score on a scale Standard Deviation 33.80	21.97 score on a scale Standard Deviation 34.10
Inflammation Score in the Frontal Recess/FSO by Clinical Investigators Day 180	24.46 score on a scale Standard Deviation 33.45	17.30 score on a scale Standard Deviation 31.45

SECONDARY outcome

Timeframe: Days 21, 45, 90 and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

Endoscopic grading of polypoid edema in the frontal recess/FSO by clinical investigators.

Polypoid edema in the frontal recess/FSO scale ranges from 0 to 3. Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=75 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=77 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators Day 21	0.88 score on a scale Standard Deviation 1.04	0.63 score on a scale Standard Deviation 0.82
Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators Day 45	0.77 score on a scale Standard Deviation 1.01	0.53 score on a scale Standard Deviation 0.87
Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators Day 90	0.80 score on a scale Standard Deviation 1.02	0.53 score on a scale Standard Deviation 0.93
Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators Day 180	0.71 score on a scale Standard Deviation 0.93	0.52 score on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Day 21, 45, 90, and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

Endoscopic grading of adhesion/scarring grade in the ethmoid sinus by clinical investigators.

The adhesion/scarring grade in the ethmoid sinus scale ranges from 0 to 4. Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=75 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=77 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators Day 21	0.30 score on a scale Standard Deviation 0.71	0.28 score on a scale Standard Deviation 0.67
Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators Day 45	0.35 score on a scale Standard Deviation 0.73	0.34 score on a scale Standard Deviation 0.72
Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators Day 90	0.39 score on a scale Standard Deviation 0.74	0.26 score on a scale Standard Deviation 0.66
Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators Day 180	0.39 score on a scale Standard Deviation 0.75	0.29 score on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: Days 21, 45, 90 and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

Endoscopic grading of polyp grade in the ethmoid sinus by clinical investigators.

Polyp grade in the ethmoid sinus scale ranges from 0 to 3. Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=77 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=77 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
Polyp Grade in the Ethmoid Sinus by Clinical Investigators Day 21	0.32 score on a scale Standard Deviation 0.62	0.29 score on a scale Standard Deviation 0.65
Polyp Grade in the Ethmoid Sinus by Clinical Investigators Day 45	0.34 score on a scale Standard Deviation 0.66	0.30 score on a scale Standard Deviation 0.61
Polyp Grade in the Ethmoid Sinus by Clinical Investigators Day 90	0.39 score on a scale Standard Deviation 0.73	0.31 score on a scale Standard Deviation 0.72
Polyp Grade in the Ethmoid Sinus by Clinical Investigators Day 180	0.31 score on a scale Standard Deviation 0.64	0.29 score on a scale Standard Deviation 0.64

SECONDARY outcome

Timeframe: Days 21, 45, 90 and 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.

Subject-reported outcome of chronic rhinosinusitis (CRS) side-specific symptom score.

The chronic rhinosinusitis side-specific symptom score scale ranges from 0 to 30. Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=76 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=77 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
CRS Side-specific Symptom Score by Subject Day 180	4.22 score on a scale Standard Deviation 4.76	3.86 score on a scale Standard Deviation 4.32
CRS Side-specific Symptom Score by Subject Day 21	6.25 score on a scale Standard Deviation 4.95	6.19 score on a scale Standard Deviation 4.74
CRS Side-specific Symptom Score by Subject Day 45	4.68 score on a scale Standard Deviation 3.90	4.75 score on a scale Standard Deviation 3.77
CRS Side-specific Symptom Score by Subject Day 90	4.42 score on a scale Standard Deviation 4.46	4.42 score on a scale Standard Deviation 4.21

SECONDARY outcome

Timeframe: Day 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable.

Subject-reported outcome of SNOT-22 score.

The Sino-Nasal Outcome Test, 22 item (SNOT-22) is a validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a 6-point scale, ranging from a score of 0 ("no problem") to 5 ("problem as bad as it can be"). The maximum total score for all symptoms is equal to 110.

Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=77 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=77 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
SNOT-22 Score by Subject	17.84 score on a scale Standard Deviation 17.62	17.84 score on a scale Standard Deviation 17.62

SECONDARY outcome

Timeframe: Day 180

Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable.

Subject-reported outcome of RSI score.

The Rhinosinusitis Symptom Inventory (RSI) scale ranges from 0 to 60. Higher scores indicate a worse outcome.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=77 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=77 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
RSI Score by Subject	7.7 score on a scale Standard Deviation 7.84	7.7 score on a scale Standard Deviation 7.84

SECONDARY outcome

Timeframe: Baseline

Number of subjects who underwent successful access and deployment of the PROPEL Contour Sinus Implant into the FSO. Delivery is considered successful if the procedure concludes with correct implant placement on the intended side, even if a second attempt to place the implant is necessary. An attempted deployment occurs when the investigator introduces the delivery system into the subject's nostril with the intent of placing an implant.

Outcome measures

Measure	Balloon Sinus Dilation Alone Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=80 Participants Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
Implant Delivery Success by Clinical Investigators	—	80 Participants

POST_HOC outcome

Timeframe: Day 45

Population: Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable.

Side-to-side difference in FSO patency at Day 45 based on cross-sectional area of FSO by CT measurements performed by an independent, blinded reviewer, as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=45 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=45 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
Difference in FSO Patency at Day 45 - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup	8.70 mm^2 Standard Deviation 12.88	14.98 mm^2 Standard Deviation 18.21

POST_HOC outcome

Timeframe: Baseline, Day 45, and Day 180

Population: Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint.

FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer, as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=44 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=44 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup Change from baseline to Day 45	0.89 mm^2 Standard Deviation 10.87	4.87 mm^2 Standard Deviation 9.59
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup Change from baseline to Day 180	7.74 mm^2 Standard Deviation 16.12	4.29 mm^2 Standard Deviation 12.46

POST_HOC outcome

Timeframe: Days 45 and 180

Population: Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint.

FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer. FSOT volume was measured via computer-assisted segmentation of CT images.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=45 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=45 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup Day 45	244.52 mm^3 Standard Deviation 394.58	306.06 mm^3 Standard Deviation 389.90
CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup Day 180	334.86 mm^3 Standard Deviation 451.20	282.89 mm^3 Standard Deviation 394.99

POST_HOC outcome

Timeframe: Days 45 and 180

Population: Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint.

CT FSO minimum diameter as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer. FSO minimum diameter was measured via computer-assisted segmentation of CT images.

Outcome measures

Measure	Balloon Sinus Dilation Alone n=45 sinus sides Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant	PROPEL Contour Sinus Implant n=45 sinus sides Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant
CT FSO Minimum Diameter by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup Day 180	2.33 mm Standard Deviation 2.23	2.18 mm Standard Deviation 2.07
CT FSO Minimum Diameter by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup Day 45	1.57 mm Standard Deviation 1.60	2.31 mm Standard Deviation 2.04

Adverse Events

PROPEL Contour Sinus Implant

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Balloon Sinus Dilation Alone

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	PROPEL Contour Sinus Implant n=80 participants at risk All sinuses exposed to the PROPEL Contour Sinus Implant	Balloon Sinus Dilation Alone n=80 participants at risk All sinuses that were not exposed to the PROPEL Contour Sinus Implant.
Nervous system disorders Loss of balance	1.2% 1/80 • From enrollment through Day 180 (end of study) A standard questionnaire was used to determine whether or not adverse events (AE) had occurred at the current follow-up visit or since the previous follow-up visit. Clinical investigators evaluated the occurrence of AEs excluding usual post-operative recovery signs and symptoms experienced by participants, unless corroborated by objective findings and/or requiring specific medical or therapeutic interventions.	1.2% 1/80 • From enrollment through Day 180 (end of study) A standard questionnaire was used to determine whether or not adverse events (AE) had occurred at the current follow-up visit or since the previous follow-up visit. Clinical investigators evaluated the occurrence of AEs excluding usual post-operative recovery signs and symptoms experienced by participants, unless corroborated by objective findings and/or requiring specific medical or therapeutic interventions.

Other adverse events

Measure	PROPEL Contour Sinus Implant n=80 participants at risk All sinuses exposed to the PROPEL Contour Sinus Implant	Balloon Sinus Dilation Alone n=80 participants at risk All sinuses that were not exposed to the PROPEL Contour Sinus Implant.
Infections and infestations Chronic sinusitis	13.8% 11/80 • From enrollment through Day 180 (end of study) A standard questionnaire was used to determine whether or not adverse events (AE) had occurred at the current follow-up visit or since the previous follow-up visit. Clinical investigators evaluated the occurrence of AEs excluding usual post-operative recovery signs and symptoms experienced by participants, unless corroborated by objective findings and/or requiring specific medical or therapeutic interventions.	16.2% 13/80 • From enrollment through Day 180 (end of study) A standard questionnaire was used to determine whether or not adverse events (AE) had occurred at the current follow-up visit or since the previous follow-up visit. Clinical investigators evaluated the occurrence of AEs excluding usual post-operative recovery signs and symptoms experienced by participants, unless corroborated by objective findings and/or requiring specific medical or therapeutic interventions.
Infections and infestations COVID-19	15.0% 12/80 • From enrollment through Day 180 (end of study) A standard questionnaire was used to determine whether or not adverse events (AE) had occurred at the current follow-up visit or since the previous follow-up visit. Clinical investigators evaluated the occurrence of AEs excluding usual post-operative recovery signs and symptoms experienced by participants, unless corroborated by objective findings and/or requiring specific medical or therapeutic interventions.	15.0% 12/80 • From enrollment through Day 180 (end of study) A standard questionnaire was used to determine whether or not adverse events (AE) had occurred at the current follow-up visit or since the previous follow-up visit. Clinical investigators evaluated the occurrence of AEs excluding usual post-operative recovery signs and symptoms experienced by participants, unless corroborated by objective findings and/or requiring specific medical or therapeutic interventions.

Additional Information

Xiaomin Deng

Medtronic plc

Phone: 707-566-1311

Email: Xiaomin.deng@medtronic.com

Results disclosure agreements

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