Trial Outcomes & Findings for Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (NCT NCT01685229)

Last Updated: 2024-07-12

Results Overview

The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks") and a total score is normalized from 0 (worst) to 100 (best). The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management. Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score). Higher score indicates greater improvement.

Recruitment status

COMPLETED

Target enrollment

198 participants

Primary outcome timeframe

24 weeks post treatment

Results posted on

2024-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Balloon Sinus Dilation Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management Subjects with chronic sinusitis electing to continue medical therapy
Overall Study STARTED	146	52
Overall Study COMPLETED	120	36
Overall Study NOT COMPLETED	26	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Balloon Sinus Dilation Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management Subjects with chronic sinusitis electing to continue medical therapy
Overall Study Subjects missing Study Exit form	3	1
Overall Study Lost to Follow-up	16	10
Overall Study Withdrawal by Subject	6	5
Overall Study Death	1	0

Baseline Characteristics

Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 Participants Subjects with chronic sinusitis electing to continue medical therapy	Total n=198 Participants Total of all reporting groups
Age, Continuous	50.5 Years STANDARD_DEVIATION 14.8 • n=99 Participants	46.4 Years STANDARD_DEVIATION 13.3 • n=107 Participants	49.4 Years STANDARD_DEVIATION 14.5 • n=206 Participants
Sex: Female, Male Female	75 Participants n=99 Participants	31 Participants n=107 Participants	106 Participants n=206 Participants
Sex: Female, Male Male	71 Participants n=99 Participants	21 Participants n=107 Participants	92 Participants n=206 Participants

PRIMARY outcome

Timeframe: 24 weeks post treatment

Population: Chronic Sinusitis Survey (CSS) Score Change from Baseline to 24 Weeks for BSD compared to MM

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 Participants Subjects with chronic sinusitis electing to continue medical therapy	Operating Room BSD subjects treating in an Operating Room venue
Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline	41.9 Scores on a scale Standard Deviation 23.7	27.0 Scores on a scale Standard Deviation 19.5	—

SECONDARY outcome

Timeframe: 12, 24, and 52 weeks post treatment

The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks"), and a total score is normalized from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement.

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 Participants Subjects with chronic sinusitis electing to continue medical therapy	Operating Room BSD subjects treating in an Operating Room venue
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Total Baseline	28.5 Scores on a scale Standard Deviation 17.9	34.3 Scores on a scale Standard Deviation 18.4	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Total Wk 52	73.3 Scores on a scale Standard Deviation 20.2	60.2 Scores on a scale Standard Deviation 22.8	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Total Wk 52 Change from Baseline	43.6 Scores on a scale Standard Deviation 21.7	29.9 Scores on a scale Standard Deviation 20.9	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Total Wk 12	68.7 Scores on a scale Standard Deviation 20.9	56.2 Scores on a scale Standard Deviation 21.3	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Total Wk 12 Change from Baseline	40.6 Scores on a scale Standard Deviation 22.7	21.9 Scores on a scale Standard Deviation 20.0	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Symptom Baseline	21.2 Scores on a scale Standard Deviation 22.3	26.4 Scores on a scale Standard Deviation 23.3	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Symptom Wk 12	71.0 Scores on a scale Standard Deviation 25.7	56.0 Scores on a scale Standard Deviation 26.9	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Symptom Wk 12 Change from Baseline	50.8 Scores on a scale Standard Deviation 28.1	31.0 Scores on a scale Standard Deviation 25.3	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Symptom Wk 24	75.1 Scores on a scale Standard Deviation 24.5	60.9 Scores on a scale Standard Deviation 27.8	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Symptom WK 24 Change from Baseline	53.7 Scores on a scale Standard Deviation 29.9	35.2 Scores on a scale Standard Deviation 31.4	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Symptom Wk 52	74.4 Scores on a scale Standard Deviation 24.0	57.7 Scores on a scale Standard Deviation 29.1	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Symptom Wk 52 Change from Baseline	51.6 Scores on a scale Standard Deviation 29.4	36.4 Scores on a scale Standard Deviation 29.7	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Medication Baseline	35.7 Scores on a scale Standard Deviation 21.4	42.1 Scores on a scale Standard Deviation 20.2	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Medication Wk 12	66.4 Scores on a scale Standard Deviation 26.0	56.4 Scores on a scale Standard Deviation 23.3	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Medication Wk 12 Change from Baseline	30.5 Scores on a scale Standard Deviation 27.4	12.9 Scores on a scale Standard Deviation 25.0	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Medication Wk 24	65.6 Scores on a scale Standard Deviation 25.8	61.7 Scores on a scale Standard Deviation 23.0	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Medication Wk 24 Change from Baseline	30.0 Scores on a scale Standard Deviation 28.8	18.8 Scores on a scale Standard Deviation 21.8	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Medication Wk 52	72.2 Scores on a scale Standard Deviation 24.8	62.7 Scores on a scale Standard Deviation 27.0	—
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline CSS Medication Wk 52 Change from Baseline	35.6 Scores on a scale Standard Deviation 24.6	23.5 Scores on a scale Standard Deviation 26.1	—

SECONDARY outcome

Timeframe: 12, 24 and 52 weeks post treatment

The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values are scored 0 ("Never") to 4 ("Always") and total score ranges from 0 (best) to 120 (worst). Subscores are summed to calculate a total score. Higher score indicates increased impact of sinus disease. The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease).

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 Participants Subjects with chronic sinusitis electing to continue medical therapy	Operating Room BSD subjects treating in an Operating Room venue
Change in RSDI RSDI Total Baseline	47.9 Scores on a scale Standard Deviation 25.3	39.5 Scores on a scale Standard Deviation 19.9	—
Change in RSDI RSDI Total Week 12	13.0 Scores on a scale Standard Deviation 17.8	26.0 Scores on a scale Standard Deviation 20.9	—
Change in RSDI RSDI Total Week 12 Change from Baseline	-34.7 Scores on a scale Standard Deviation 24.2	-14.7 Scores on a scale Standard Deviation 17.2	—
Change in RSDI RSDI Total Week 24	11.6 Scores on a scale Standard Deviation 19.0	22.6 Scores on a scale Standard Deviation 23.2	—
Change in RSDI RSDI Total Week 24 Change from Baseline	-36.0 Scores on a scale Standard Deviation 26.4	-18.1 Scores on a scale Standard Deviation 16.8	—
Change in RSDI RSDI Total Week 52	9.8 Scores on a scale Standard Deviation 19.1	18.7 Scores on a scale Standard Deviation 20.0	—
Change in RSDI RSDI Total Week 52 Change from Baseline	-36.5 Scores on a scale Standard Deviation 24.9	-19.9 Scores on a scale Standard Deviation 19.6	—
Change in RSDI RSDI Physical Baseline	19.4 Scores on a scale Standard Deviation 9.7	16.8 Scores on a scale Standard Deviation 7.3	—
Change in RSDI RSDI Physical Week 12	5.4 Scores on a scale Standard Deviation 7.0	11.4 Scores on a scale Standard Deviation 8.7	—
Change in RSDI RSDI Physical Week 12 Change from Baseline	-13.9 Scores on a scale Standard Deviation 9.4	-6.0 Scores on a scale Standard Deviation 7.5	—
Change in RSDI RSDI Physical Week 24	5.0 Scores on a scale Standard Deviation 7.7	10.1 Scores on a scale Standard Deviation 9.3	—
Change in RSDI RSDI Physical Week 24 Change from Baseline	-14.1 Scores on a scale Standard Deviation 10.4	-7.3 Scores on a scale Standard Deviation 7.1	—
Change in RSDI RSDI Physical Week 52	4.4 Scores on a scale Standard Deviation 7.2	9.2 Scores on a scale Standard Deviation 9.7	—
Change in RSDI RSDI Physical Week 52 Change from Baseline	-14.3 Scores on a scale Standard Deviation 9.9	-7.9 Scores on a scale Standard Deviation 8.1	—
Change in RSDI RSDI Functional Baseline	14.9 Scores on a scale Standard Deviation 8.3	11.5 Scores on a scale Standard Deviation 7.0	—
Change in RSDI RSDI Functional Week 12	4.0 Scores on a scale Standard Deviation 6.1	7.3 Scores on a scale Standard Deviation 6.6	—
Change in RSDI RSDI Functional Week 12 Change from Baseline	-10.9 Scores on a scale Standard Deviation 8.2	-4.8 Scores on a scale Standard Deviation 5.2	—
Change in RSDI RSDI Functional Week 24	3.5 Scores on a scale Standard Deviation 6.0	6.5 Scores on a scale Standard Deviation 7.2	—
Change in RSDI RSDI Functional Week 24 Change from Baseline	-11.4 Scores on a scale Standard Deviation 8.5	-5.4 Scores on a scale Standard Deviation 5.1	—
Change in RSDI RSDI Functional Week 52	2.9 Scores on a scale Standard Deviation 6.2	5.4 Scores on a scale Standard Deviation 5.9	—
Change in RSDI RSDI Functional Week 52 Change from Baseline	-11.5 Scores on a scale Standard Deviation 8.1	-5.7 Scores on a scale Standard Deviation 6.7	—
Change in RSDI RSDI Emotional Baseline	13.6 Scores on a scale Standard Deviation 9.7	11.3 Scores on a scale Standard Deviation 7.6	—
Change in RSDI RSDI Emotional Week 12	3.7 Scores on a scale Standard Deviation 5.7	7.5 Scores on a scale Standard Deviation 7.2	—
Change in RSDI RSDI Emotional Week 12 Change from Baseline	-9.9 Scores on a scale Standard Deviation 9.4	-3.4 Scores on a scale Standard Deviation 6.1	—
Change in RSDI RSDI Emotional Week 24	3.1 Scores on a scale Standard Deviation 6.0	5.9 Scores on a scale Standard Deviation 7.9	—
Change in RSDI RSDI Emotional Week 24 Change from Baseline	-10.5 Scores on a scale Standard Deviation 9.8	-5.4 Scores on a scale Standard Deviation 6.7	—
Change in RSDI RSDI Emotional Week 52	2.5 Scores on a scale Standard Deviation 6.4	4.1 Scores on a scale Standard Deviation 5.4	—
Change in RSDI RSDI Emotional Week 52 Change from Baseline	-10.7 Scores on a scale Standard Deviation 9.5	-6.3 Scores on a scale Standard Deviation 7.0	—

SECONDARY outcome

Timeframe: 12 weeks, 24 weeks, 52 weeks post treatment

The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments. Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be). Lower score indicates greater improvement.

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 Participants Subjects with chronic sinusitis electing to continue medical therapy	Operating Room BSD subjects treating in an Operating Room venue
Change in SNOT-20 SNOT-20 Total Baseline	2.5 Scores on a scale Standard Deviation 1.0	2.4 Scores on a scale Standard Deviation 0.9	—
Change in SNOT-20 SNOT-20 Symptom Week 12	0.9 Scores on a scale Standard Deviation 0.8	1.5 Scores on a scale Standard Deviation 0.9	—
Change in SNOT-20 SNOT-20 Symptom Week 12 Change from Baseline	-1.6 Scores on a scale Standard Deviation 1.1	-0.9 Scores on a scale Standard Deviation 1.0	—
Change in SNOT-20 SNOT-20 Symptom Week 24	0.9 Scores on a scale Standard Deviation 0.8	1.5 Scores on a scale Standard Deviation 1.0	—
Change in SNOT-20 SNOT-20 Symptom Week 24 Change from Baseline	-1.7 Scores on a scale Standard Deviation 1.1	-1.0 Scores on a scale Standard Deviation 1.1	—
Change in SNOT-20 SNOT-20 Symptom Week 52	0.9 Scores on a scale Standard Deviation 0.8	1.3 Scores on a scale Standard Deviation 0.9	—
Change in SNOT-20 SNOT-20 Symptom Week 52 Change from Baseline	-1.7 Scores on a scale Standard Deviation 1.2	-1.2 Scores on a scale Standard Deviation 1.0	—
Change in SNOT-20 SNOT-20 Social-Emotional Baseline	2.4 Scores on a scale Standard Deviation 1.2	2.3 Scores on a scale Standard Deviation 1.1	—
Change in SNOT-20 SNOT-20 Social-Emotional Week 12	0.7 Scores on a scale Standard Deviation 0.9	1.4 Scores on a scale Standard Deviation 1.0	—
Change in SNOT-20 SNOT-20 Social-Emotional Week 12 Change	-1.7 Scores on a scale Standard Deviation 1.2	-0.9 Scores on a scale Standard Deviation 0.9	—
Change in SNOT-20 SNOT-20 Social-Emotional Week 24	0.8 Scores on a scale Standard Deviation 1.0	1.3 Scores on a scale Standard Deviation 1.1	—
Change in SNOT-20 SNOT-20 Social-Emotional Week 24 Change	-1.6 Scores on a scale Standard Deviation 1.2	-1.0 Scores on a scale Standard Deviation 1.0	—
Change in SNOT-20 SNOT-20 Social-Emotional Week 52	0.7 Scores on a scale Standard Deviation 0.9	1.0 Scores on a scale Standard Deviation 0.8	—
Change in SNOT-20 SNOT-20 Social-Emotional Week 52 Change	-1.6 Scores on a scale Standard Deviation 1.4	-1.3 Scores on a scale Standard Deviation 1.0	—
Change in SNOT-20 SNOT-20 Total Week 12	0.8 Scores on a scale Standard Deviation 0.8	1.4 Scores on a scale Standard Deviation 0.9	—
Change in SNOT-20 SNOT-20 Total Week 12 Change from Baseline	-1.6 Scores on a scale Standard Deviation 1.0	-0.9 Scores on a scale Standard Deviation 0.8	—
Change in SNOT-20 SNOT-20 Total Week 24	0.8 Scores on a scale Standard Deviation 0.8	1.4 Scores on a scale Standard Deviation 1.0	—
Change in SNOT-20 SNOT-20 Total Week 24 Change from Baseline	-1.6 Scores on a scale Standard Deviation 1.1	-1.0 Scores on a scale Standard Deviation 1.0	—
Change in SNOT-20 SNOT-20 Total Week 52	0.8 Scores on a scale Standard Deviation 0.8	1.2 Scores on a scale Standard Deviation 0.8	—
Change in SNOT-20 SNOT-20 Total Week 52 Change from Baseline	-1.7 Scores on a scale Standard Deviation 1.2	-1.2 Scores on a scale Standard Deviation 0.9	—
Change in SNOT-20 SNOT-20 Symptom Baseline	2.6 Scores on a scale Standard Deviation 1.0	2.6 Scores on a scale Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: 12, 24 and 52 weeks post treatment

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 Participants Subjects with chronic sinusitis electing to continue medical therapy	Operating Room BSD subjects treating in an Operating Room venue
Change in Disease-specific Medication Usage Oral Antibiotics Baseline	28.1 Medications Standard Deviation 15.4	22.8 Medications Standard Deviation 6.1	—
Change in Disease-specific Medication Usage Oral Antibiotics Week 12	5.7 Medications Standard Deviation 8.4	6.6 Medications Standard Deviation 9.5	—
Change in Disease-specific Medication Usage Oral Antibiotics Week 12 Change from Baseline	-22.2 Medications Standard Deviation 17.0	-16.7 Medications Standard Deviation 11.4	—
Change in Disease-specific Medication Usage Oral Antibiotics Week 24	2.3 Medications Standard Deviation 6.6	2.8 Medications Standard Deviation 6.7	—
Change in Disease-specific Medication Usage Oral Antibiotics Week 24 Change from Baseline	-25.9 Medications Standard Deviation 15.8	-20.5 Medications Standard Deviation 10.1	—
Change in Disease-specific Medication Usage Oral Antibiotics Week 52	2.0 Medications Standard Deviation 5.9	1.8 Medications Standard Deviation 5.5	—
Change in Disease-specific Medication Usage Oral Antibiotics Week 52 Change from Baseline	-25.8 Medications Standard Deviation 15.5	-22.4 Medications Standard Deviation 8.5	—
Change in Disease-specific Medication Usage Oral Steroids Baseline	7.9 Medications Standard Deviation 10.4	8.4 Medications Standard Deviation 10.0	—
Change in Disease-specific Medication Usage Oral Steroids Week 12	3.0 Medications Standard Deviation 9.8	2.6 Medications Standard Deviation 7.0	—
Change in Disease-specific Medication Usage Oral Steroids Week 12 Change from Baseline	-4.9 Medications Standard Deviation 13.7	-6.5 Medications Standard Deviation 10.6	—
Change in Disease-specific Medication Usage Oral Steroids Week 24	0.8 Medications Standard Deviation 3.6	0.7 Medications Standard Deviation 2.8	—
Change in Disease-specific Medication Usage Oral Steroids Week 24 Change from Baseline	-6.5 Medications Standard Deviation 9.9	-7.9 Medications Standard Deviation 9.3	—
Change in Disease-specific Medication Usage Oral Steroids Week 52	2.5 Medications Standard Deviation 13.9	2.6 Medications Standard Deviation 9.1	—
Change in Disease-specific Medication Usage Oral Steroids Week 52 Change from Baseline	-4.5 Medications Standard Deviation 17.0	-6.4 Medications Standard Deviation 14.4	—
Change in Disease-specific Medication Usage Nasal Steroid Spray Baseline	53.0 Medications Standard Deviation 29.6	47.2 Medications Standard Deviation 28.1	—
Change in Disease-specific Medication Usage Nasal Steroid Spray Week 12	39.7 Medications Standard Deviation 40.3	69.1 Medications Standard Deviation 35.5	—
Change in Disease-specific Medication Usage Nasal Steroid Spray Week 12 Change from Baseline	-13.3 Medications Standard Deviation 44.2	21.1 Medications Standard Deviation 44.1	—
Change in Disease-specific Medication Usage Nasal Steroid Spray Week 24	44.6 Medications Standard Deviation 42.6	66.0 Medications Standard Deviation 35.5	—
Change in Disease-specific Medication Usage Nasal Steroid Spray Week 24 Change from Baseline	-9.1 Medications Standard Deviation 46.6	18.4 Medications Standard Deviation 45.5	—
Change in Disease-specific Medication Usage Nasal Steroid Spray Week 52	34.8 Medications Standard Deviation 41.1	57.0 Medications Standard Deviation 39.7	—
Change in Disease-specific Medication Usage Nasal Steroid Spray Week 52 Change from Baseline	-17.5 Medications Standard Deviation 46.0	10.0 Medications Standard Deviation 52.1	—

SECONDARY outcome

Timeframe: 12, 24 and 52 weeks post treatment

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 Participants Subjects with chronic sinusitis electing to continue medical therapy	Operating Room BSD subjects treating in an Operating Room venue
Missed Days Work/School Baseline	3.0 Days Standard Deviation 9.2	1.4 Days Standard Deviation 2.4	—
Missed Days Work/School Wk 24	0.2 Days Standard Deviation 0.8	0.0 Days Standard Deviation 0.0	—
Missed Days Work/School Wk 52	0.4 Days Standard Deviation 2.9	0.1 Days Standard Deviation 0.4	—
Missed Days Work/School Wk 24 Change from Baseline	-2.0 Days Standard Deviation 4.4	-1.3 Days Standard Deviation 2.2	—
Missed Days Work/School Wk 52 Change from Baseline	-1.5 Days Standard Deviation 3.9	-1.2 Days Standard Deviation 2.2	—

SECONDARY outcome

Timeframe: 12 weeks, 24 weeks, 52 weeks post treatment

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 Participants Subjects with chronic sinusitis electing to continue medical therapy	Operating Room BSD subjects treating in an Operating Room venue
Number of Sinus-related Medical Care Visits Sinus-Related Visits at Baseline	2.0 Visits Standard Deviation 2.1	1.2 Visits Standard Deviation 1.6	—
Number of Sinus-related Medical Care Visits Sinus-Related Visits through 12 weeks	0.1 Visits Standard Deviation 0.3	0.1 Visits Standard Deviation 0.5	—
Number of Sinus-related Medical Care Visits Sinus-Related Visits through 24 weeks	0.1 Visits Standard Deviation 0.4	0.1 Visits Standard Deviation 0.6	—
Number of Sinus-related Medical Care Visits Sinus-Related Visits through 52 weeks	0.2 Visits Standard Deviation 0.5	0.1 Visits Standard Deviation 0.6	—

SECONDARY outcome

Timeframe: 24 and 52 weeks

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 Participants Subjects with chronic sinusitis electing to continue medical therapy	Operating Room BSD subjects treating in an Operating Room venue
Number of Sinus Infections Sinus Infections through 24 weeks	0.3 Sinus infections Standard Deviation 0.6	0.3 Sinus infections Standard Deviation 0.6	—
Number of Sinus Infections Sinus Infections through 52 weeks	0.5 Sinus infections Standard Deviation 0.8	0.6 Sinus infections Standard Deviation 0.8	—

SECONDARY outcome

Timeframe: 52 weeks

A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure.

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 Participants Subjects with chronic sinusitis electing to continue medical therapy	Operating Room BSD subjects treating in an Operating Room venue
Number of Subjects Requiring Revision for Subjects Electing BSD	3 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 52 weeks

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=52 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management Subjects with chronic sinusitis electing to continue medical therapy	Operating Room BSD subjects treating in an Operating Room venue
Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure	12 Participants	—	—

SECONDARY outcome

Timeframe: 2 weeks post treatment

Outcome measures

Outcome measures
Measure	Balloon Sinus Dilation n=146 Participants Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=105 Participants Subjects with chronic sinusitis electing to continue medical therapy	Operating Room n=41 Participants BSD subjects treating in an Operating Room venue
Post-operative Return to Normal Activity (RTNA)	3.6 Days Standard Deviation 4.1	2.8 Days Standard Deviation 3.7	5.9 Days Standard Deviation 4.1

Adverse Events

Balloon Sinus Dilation

Serious events: 6 serious events

Other events: 49 other events

Deaths: 1 deaths

Medical Management

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Balloon Sinus Dilation n=146 participants at risk Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 participants at risk Subjects with chronic sinusitis electing to continue medical therapy
Gastrointestinal disorders GI Bleeding	0.68% 1/146 • Number of events 1 No AEs were related to the device	0.00% 0/52 No AEs were related to the device
General disorders Fever	0.68% 1/146 • Number of events 1 No AEs were related to the device	0.00% 0/52 No AEs were related to the device
Hepatobiliary disorders Pancreatitis	0.68% 1/146 • Number of events 1 No AEs were related to the device	0.00% 0/52 No AEs were related to the device
Immune system disorders Neuropenic Shock	0.68% 1/146 • Number of events 1 No AEs were related to the device	0.00% 0/52 No AEs were related to the device
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer, Glioblastoma	1.4% 2/146 • Number of events 2 No AEs were related to the device	0.00% 0/52 No AEs were related to the device
Nervous system disorders Bells Palsy, TIA	1.4% 2/146 • Number of events 2 No AEs were related to the device	0.00% 0/52 No AEs were related to the device
Respiratory, thoracic and mediastinal disorders Dyspnea	0.68% 1/146 • Number of events 1 No AEs were related to the device	0.00% 0/52 No AEs were related to the device

Other adverse events

Other adverse events
Measure	Balloon Sinus Dilation n=146 participants at risk Subjects with chronic sinusitis electing to have a balloon sinus dilation	Medical Management n=52 participants at risk Subjects with chronic sinusitis electing to continue medical therapy
Respiratory, thoracic and mediastinal disorders Bronchitis	4.8% 7/146 • Number of events 7 No AEs were related to the device	5.8% 3/52 • Number of events 3 No AEs were related to the device
Respiratory, thoracic and mediastinal disorders Sinusitis	20.5% 30/146 • Number of events 38 No AEs were related to the device	7.7% 4/52 • Number of events 4 No AEs were related to the device
Respiratory, thoracic and mediastinal disorders URI	8.2% 12/146 • Number of events 14 No AEs were related to the device	1.9% 1/52 • Number of events 1 No AEs were related to the device

Additional Information

Clinical Manager

Acclarent Inc.

Phone: 949-453-6408

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60