Sinusitis
Conditions
Brief summary
This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
Interventions
DEVICEBalloon sinus dilation
Subjects electing continued medical therapy group will not have balloon sinus dilation intervention. Subjects electing balloon sinus dilation group will have balloon sinus dilation intervention.
DRUGMedical Management
Subjects who select to continue on medical management rather than have a BSD procedure.
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females aged 19 or greater * Diagnosis of Chronic Rhinosinusitis (CRS) * Failure of appropriate medical management * Radiographic evidence of inflammation of the paranasal sinuses * Surgical candidate * Willing and able to read and sign the Informed Consent Form and remain compliant with the protocol and study procedures * Able to read and understand English
Exclusion criteria
* Not suitable for balloon dilation for all peripheral sinuses that require treatment * Clinically significant illness that may interfere with the evaluation of the study * Patients involved in other clinical studies 30 days prior to study * Pregnant or lactating females * Patients unable to adhere to follow-up schedule or protocol requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline | 24 weeks post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in RSDI | 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). |
| Change in SNOT-20 | 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. |
| Change in Disease-specific Medication Usage | 12, 24 and 52 weeks post treatment | — |
| Missed Days Work/School | 12, 24 and 52 weeks post treatment | — |
| Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | 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. |
| Number of Sinus Infections | 24 and 52 weeks | — |
| Number of Subjects Requiring Revision for Subjects Electing BSD | 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. |
| Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure | 52 weeks | — |
| Post-operative Return to Normal Activity (RTNA) | 2 weeks post treatment | — |
| Number of Sinus-related Medical Care Visits | 12 weeks, 24 weeks, 52 weeks post treatment | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balloon Sinus Dilation Subjects with chronic sinusitis electing to have a balloon sinus dilation | 146 |
| Medical Management Subjects with chronic sinusitis electing to continue medical therapy | 52 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 16 | 10 |
| Overall Study | Subjects missing Study Exit form | 3 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | Balloon Sinus Dilation | Medical Management | Total |
|---|---|---|---|
| Age, Continuous | 50.5 Years STANDARD_DEVIATION 14.8 | 46.4 Years STANDARD_DEVIATION 13.3 | 49.4 Years STANDARD_DEVIATION 14.5 |
| Sex: Female, Male Female | 75 Participants | 31 Participants | 106 Participants |
| Sex: Female, Male Male | 71 Participants | 21 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 146 | 0 / 52 |
| other Total, other adverse events | 49 / 146 | 8 / 52 |
| serious Total, serious adverse events | 6 / 146 | 0 / 52 |
Outcome results
Primary
Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline
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.
Time frame: 24 weeks post treatment
Population: Chronic Sinusitis Survey (CSS) Score Change from Baseline to 24 Weeks for BSD compared to MM
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinus Dilation | 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 |
| Medical Management | Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline | 27.0 Scores on a scale | Standard Deviation 19.5 |
Secondary
Change in Disease-specific Medication Usage
Time frame: 12, 24 and 52 weeks post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Antibiotics Baseline | 28.1 Medications | Standard Deviation 15.4 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Antibiotics Week 12 | 5.7 Medications | Standard Deviation 8.4 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Antibiotics Week 12 Change from Baseline | -22.2 Medications | Standard Deviation 17 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Antibiotics Week 24 | 2.3 Medications | Standard Deviation 6.6 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Antibiotics Week 24 Change from Baseline | -25.9 Medications | Standard Deviation 15.8 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Antibiotics Week 52 | 2.0 Medications | Standard Deviation 5.9 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Antibiotics Week 52 Change from Baseline | -25.8 Medications | Standard Deviation 15.5 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Steroids Baseline | 7.9 Medications | Standard Deviation 10.4 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Steroids Week 12 | 3.0 Medications | Standard Deviation 9.8 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Steroids Week 12 Change from Baseline | -4.9 Medications | Standard Deviation 13.7 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Steroids Week 24 | 0.8 Medications | Standard Deviation 3.6 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Steroids Week 24 Change from Baseline | -6.5 Medications | Standard Deviation 9.9 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Steroids Week 52 | 2.5 Medications | Standard Deviation 13.9 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Oral Steroids Week 52 Change from Baseline | -4.5 Medications | Standard Deviation 17 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Nasal Steroid Spray Baseline | 53.0 Medications | Standard Deviation 29.6 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 12 | 39.7 Medications | Standard Deviation 40.3 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 12 Change from Baseline | -13.3 Medications | Standard Deviation 44.2 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 24 | 44.6 Medications | Standard Deviation 42.6 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 24 Change from Baseline | -9.1 Medications | Standard Deviation 46.6 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 52 | 34.8 Medications | Standard Deviation 41.1 |
| Balloon Sinus Dilation | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 52 Change from Baseline | -17.5 Medications | Standard Deviation 46 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Steroids Week 24 | 0.7 Medications | Standard Deviation 2.8 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Antibiotics Baseline | 22.8 Medications | Standard Deviation 6.1 |
| Medical Management | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 24 Change from Baseline | 18.4 Medications | Standard Deviation 45.5 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Antibiotics Week 12 | 6.6 Medications | Standard Deviation 9.5 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Steroids Week 24 Change from Baseline | -7.9 Medications | Standard Deviation 9.3 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Antibiotics Week 12 Change from Baseline | -16.7 Medications | Standard Deviation 11.4 |
| Medical Management | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 12 Change from Baseline | 21.1 Medications | Standard Deviation 44.1 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Antibiotics Week 24 | 2.8 Medications | Standard Deviation 6.7 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Steroids Week 52 | 2.6 Medications | Standard Deviation 9.1 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Antibiotics Week 24 Change from Baseline | -20.5 Medications | Standard Deviation 10.1 |
| Medical Management | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 52 Change from Baseline | 10.0 Medications | Standard Deviation 52.1 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Antibiotics Week 52 | 1.8 Medications | Standard Deviation 5.5 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Steroids Week 52 Change from Baseline | -6.4 Medications | Standard Deviation 14.4 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Antibiotics Week 52 Change from Baseline | -22.4 Medications | Standard Deviation 8.5 |
| Medical Management | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 24 | 66.0 Medications | Standard Deviation 35.5 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Steroids Baseline | 8.4 Medications | Standard Deviation 10 |
| Medical Management | Change in Disease-specific Medication Usage | Nasal Steroid Spray Baseline | 47.2 Medications | Standard Deviation 28.1 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Steroids Week 12 | 2.6 Medications | Standard Deviation 7 |
| Medical Management | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 52 | 57.0 Medications | Standard Deviation 39.7 |
| Medical Management | Change in Disease-specific Medication Usage | Oral Steroids Week 12 Change from Baseline | -6.5 Medications | Standard Deviation 10.6 |
| Medical Management | Change in Disease-specific Medication Usage | Nasal Steroid Spray Week 12 | 69.1 Medications | Standard Deviation 35.5 |
Secondary
Change in RSDI
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).
Time frame: 12, 24 and 52 weeks post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Change in RSDI | RSDI Functional Baseline | 14.9 Scores on a scale | Standard Deviation 8.3 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Total Week 52 Change from Baseline | -36.5 Scores on a scale | Standard Deviation 24.9 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Functional Week 12 | 4.0 Scores on a scale | Standard Deviation 6.1 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Physical Week 12 | 5.4 Scores on a scale | Standard Deviation 7 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Functional Week 12 Change from Baseline | -10.9 Scores on a scale | Standard Deviation 8.2 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Physical Baseline | 19.4 Scores on a scale | Standard Deviation 9.7 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Functional Week 24 | 3.5 Scores on a scale | Standard Deviation 6 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Total Week 24 | 11.6 Scores on a scale | Standard Deviation 19 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Functional Week 24 Change from Baseline | -11.4 Scores on a scale | Standard Deviation 8.5 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Physical Week 12 Change from Baseline | -13.9 Scores on a scale | Standard Deviation 9.4 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Functional Week 52 | 2.9 Scores on a scale | Standard Deviation 6.2 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Total Week 12 | 13.0 Scores on a scale | Standard Deviation 17.8 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Functional Week 52 Change from Baseline | -11.5 Scores on a scale | Standard Deviation 8.1 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Physical Week 24 | 5.0 Scores on a scale | Standard Deviation 7.7 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Emotional Baseline | 13.6 Scores on a scale | Standard Deviation 9.7 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Total Week 24 Change from Baseline | -36.0 Scores on a scale | Standard Deviation 26.4 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Emotional Week 12 | 3.7 Scores on a scale | Standard Deviation 5.7 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Physical Week 24 Change from Baseline | -14.1 Scores on a scale | Standard Deviation 10.4 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Emotional Week 12 Change from Baseline | -9.9 Scores on a scale | Standard Deviation 9.4 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Total Baseline | 47.9 Scores on a scale | Standard Deviation 25.3 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Emotional Week 24 | 3.1 Scores on a scale | Standard Deviation 6 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Physical Week 52 | 4.4 Scores on a scale | Standard Deviation 7.2 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Emotional Week 24 Change from Baseline | -10.5 Scores on a scale | Standard Deviation 9.8 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Total Week 52 | 9.8 Scores on a scale | Standard Deviation 19.1 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Emotional Week 52 | 2.5 Scores on a scale | Standard Deviation 6.4 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Physical Week 52 Change from Baseline | -14.3 Scores on a scale | Standard Deviation 9.9 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Emotional Week 52 Change from Baseline | -10.7 Scores on a scale | Standard Deviation 9.5 |
| Balloon Sinus Dilation | Change in RSDI | RSDI Total Week 12 Change from Baseline | -34.7 Scores on a scale | Standard Deviation 24.2 |
| Medical Management | Change in RSDI | RSDI Emotional Week 52 Change from Baseline | -6.3 Scores on a scale | Standard Deviation 7 |
| Medical Management | Change in RSDI | RSDI Total Baseline | 39.5 Scores on a scale | Standard Deviation 19.9 |
| Medical Management | Change in RSDI | RSDI Total Week 12 | 26.0 Scores on a scale | Standard Deviation 20.9 |
| Medical Management | Change in RSDI | RSDI Total Week 12 Change from Baseline | -14.7 Scores on a scale | Standard Deviation 17.2 |
| Medical Management | Change in RSDI | RSDI Total Week 24 | 22.6 Scores on a scale | Standard Deviation 23.2 |
| Medical Management | Change in RSDI | RSDI Total Week 24 Change from Baseline | -18.1 Scores on a scale | Standard Deviation 16.8 |
| Medical Management | Change in RSDI | RSDI Total Week 52 | 18.7 Scores on a scale | Standard Deviation 20 |
| Medical Management | Change in RSDI | RSDI Total Week 52 Change from Baseline | -19.9 Scores on a scale | Standard Deviation 19.6 |
| Medical Management | Change in RSDI | RSDI Physical Week 12 | 11.4 Scores on a scale | Standard Deviation 8.7 |
| Medical Management | Change in RSDI | RSDI Physical Week 12 Change from Baseline | -6.0 Scores on a scale | Standard Deviation 7.5 |
| Medical Management | Change in RSDI | RSDI Physical Week 24 | 10.1 Scores on a scale | Standard Deviation 9.3 |
| Medical Management | Change in RSDI | RSDI Physical Week 24 Change from Baseline | -7.3 Scores on a scale | Standard Deviation 7.1 |
| Medical Management | Change in RSDI | RSDI Physical Week 52 | 9.2 Scores on a scale | Standard Deviation 9.7 |
| Medical Management | Change in RSDI | RSDI Physical Week 52 Change from Baseline | -7.9 Scores on a scale | Standard Deviation 8.1 |
| Medical Management | Change in RSDI | RSDI Functional Baseline | 11.5 Scores on a scale | Standard Deviation 7 |
| Medical Management | Change in RSDI | RSDI Functional Week 12 | 7.3 Scores on a scale | Standard Deviation 6.6 |
| Medical Management | Change in RSDI | RSDI Functional Week 12 Change from Baseline | -4.8 Scores on a scale | Standard Deviation 5.2 |
| Medical Management | Change in RSDI | RSDI Functional Week 24 | 6.5 Scores on a scale | Standard Deviation 7.2 |
| Medical Management | Change in RSDI | RSDI Functional Week 24 Change from Baseline | -5.4 Scores on a scale | Standard Deviation 5.1 |
| Medical Management | Change in RSDI | RSDI Functional Week 52 | 5.4 Scores on a scale | Standard Deviation 5.9 |
| Medical Management | Change in RSDI | RSDI Functional Week 52 Change from Baseline | -5.7 Scores on a scale | Standard Deviation 6.7 |
| Medical Management | Change in RSDI | RSDI Emotional Baseline | 11.3 Scores on a scale | Standard Deviation 7.6 |
| Medical Management | Change in RSDI | RSDI Emotional Week 12 | 7.5 Scores on a scale | Standard Deviation 7.2 |
| Medical Management | Change in RSDI | RSDI Emotional Week 12 Change from Baseline | -3.4 Scores on a scale | Standard Deviation 6.1 |
| Medical Management | Change in RSDI | RSDI Emotional Week 24 | 5.9 Scores on a scale | Standard Deviation 7.9 |
| Medical Management | Change in RSDI | RSDI Emotional Week 24 Change from Baseline | -5.4 Scores on a scale | Standard Deviation 6.7 |
| Medical Management | Change in RSDI | RSDI Emotional Week 52 | 4.1 Scores on a scale | Standard Deviation 5.4 |
| Medical Management | Change in RSDI | RSDI Physical Baseline | 16.8 Scores on a scale | Standard Deviation 7.3 |
Secondary
Change in SNOT-20
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.
Time frame: 12 weeks, 24 weeks, 52 weeks post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Total Baseline | 2.5 Scores on a scale | Standard Deviation 1 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Symptom Week 12 | 0.9 Scores on a scale | Standard Deviation 0.8 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Symptom Week 12 Change from Baseline | -1.6 Scores on a scale | Standard Deviation 1.1 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Symptom Week 24 | 0.9 Scores on a scale | Standard Deviation 0.8 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Symptom Week 24 Change from Baseline | -1.7 Scores on a scale | Standard Deviation 1.1 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Symptom Week 52 | 0.9 Scores on a scale | Standard Deviation 0.8 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Symptom Week 52 Change from Baseline | -1.7 Scores on a scale | Standard Deviation 1.2 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Social-Emotional Baseline | 2.4 Scores on a scale | Standard Deviation 1.2 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Social-Emotional Week 12 | 0.7 Scores on a scale | Standard Deviation 0.9 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Social-Emotional Week 12 Change | -1.7 Scores on a scale | Standard Deviation 1.2 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Social-Emotional Week 24 | 0.8 Scores on a scale | Standard Deviation 1 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Social-Emotional Week 24 Change | -1.6 Scores on a scale | Standard Deviation 1.2 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Social-Emotional Week 52 | 0.7 Scores on a scale | Standard Deviation 0.9 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Social-Emotional Week 52 Change | -1.6 Scores on a scale | Standard Deviation 1.4 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Total Week 12 | 0.8 Scores on a scale | Standard Deviation 0.8 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Total Week 12 Change from Baseline | -1.6 Scores on a scale | Standard Deviation 1 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Total Week 24 | 0.8 Scores on a scale | Standard Deviation 0.8 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Total Week 24 Change from Baseline | -1.6 Scores on a scale | Standard Deviation 1.1 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Total Week 52 | 0.8 Scores on a scale | Standard Deviation 0.8 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Total Week 52 Change from Baseline | -1.7 Scores on a scale | Standard Deviation 1.2 |
| Balloon Sinus Dilation | Change in SNOT-20 | SNOT-20 Symptom Baseline | 2.6 Scores on a scale | Standard Deviation 1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Social-Emotional Week 24 | 1.3 Scores on a scale | Standard Deviation 1.1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Total Baseline | 2.4 Scores on a scale | Standard Deviation 0.9 |
| Medical Management | Change in SNOT-20 | SNOT-20 Total Week 52 | 1.2 Scores on a scale | Standard Deviation 0.8 |
| Medical Management | Change in SNOT-20 | SNOT-20 Symptom Week 12 | 1.5 Scores on a scale | Standard Deviation 0.9 |
| Medical Management | Change in SNOT-20 | SNOT-20 Social-Emotional Week 24 Change | -1.0 Scores on a scale | Standard Deviation 1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Symptom Week 12 Change from Baseline | -0.9 Scores on a scale | Standard Deviation 1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Total Week 24 | 1.4 Scores on a scale | Standard Deviation 1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Symptom Week 24 | 1.5 Scores on a scale | Standard Deviation 1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Social-Emotional Week 52 | 1.0 Scores on a scale | Standard Deviation 0.8 |
| Medical Management | Change in SNOT-20 | SNOT-20 Symptom Week 24 Change from Baseline | -1.0 Scores on a scale | Standard Deviation 1.1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Symptom Baseline | 2.6 Scores on a scale | Standard Deviation 0.9 |
| Medical Management | Change in SNOT-20 | SNOT-20 Symptom Week 52 | 1.3 Scores on a scale | Standard Deviation 0.9 |
| Medical Management | Change in SNOT-20 | SNOT-20 Social-Emotional Week 52 Change | -1.3 Scores on a scale | Standard Deviation 1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Symptom Week 52 Change from Baseline | -1.2 Scores on a scale | Standard Deviation 1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Total Week 24 Change from Baseline | -1.0 Scores on a scale | Standard Deviation 1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Social-Emotional Baseline | 2.3 Scores on a scale | Standard Deviation 1.1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Total Week 12 | 1.4 Scores on a scale | Standard Deviation 0.9 |
| Medical Management | Change in SNOT-20 | SNOT-20 Social-Emotional Week 12 | 1.4 Scores on a scale | Standard Deviation 1 |
| Medical Management | Change in SNOT-20 | SNOT-20 Total Week 52 Change from Baseline | -1.2 Scores on a scale | Standard Deviation 0.9 |
| Medical Management | Change in SNOT-20 | SNOT-20 Social-Emotional Week 12 Change | -0.9 Scores on a scale | Standard Deviation 0.9 |
| Medical Management | Change in SNOT-20 | SNOT-20 Total Week 12 Change from Baseline | -0.9 Scores on a scale | Standard Deviation 0.8 |
Secondary
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline
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.
Time frame: 12, 24, and 52 weeks post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Medication Wk 52 Change from Baseline | 23.5 Scores on a scale | Standard Deviation 26.1 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Total Baseline | 34.3 Scores on a scale | Standard Deviation 18.4 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Total Wk 52 | 60.2 Scores on a scale | Standard Deviation 22.8 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Total Wk 52 Change from Baseline | 29.9 Scores on a scale | Standard Deviation 20.9 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Total Wk 12 | 56.2 Scores on a scale | Standard Deviation 21.3 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Total Wk 12 Change from Baseline | 21.9 Scores on a scale | Standard Deviation 20 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Symptom Baseline | 26.4 Scores on a scale | Standard Deviation 23.3 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Symptom Wk 12 | 56.0 Scores on a scale | Standard Deviation 26.9 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Symptom Wk 12 Change from Baseline | 31.0 Scores on a scale | Standard Deviation 25.3 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Symptom Wk 24 | 60.9 Scores on a scale | Standard Deviation 27.8 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Symptom WK 24 Change from Baseline | 35.2 Scores on a scale | Standard Deviation 31.4 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Symptom Wk 52 | 57.7 Scores on a scale | Standard Deviation 29.1 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Symptom Wk 52 Change from Baseline | 36.4 Scores on a scale | Standard Deviation 29.7 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Medication Baseline | 42.1 Scores on a scale | Standard Deviation 20.2 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Medication Wk 12 | 56.4 Scores on a scale | Standard Deviation 23.3 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Medication Wk 12 Change from Baseline | 12.9 Scores on a scale | Standard Deviation 25 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Medication Wk 24 | 61.7 Scores on a scale | Standard Deviation 23 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Medication Wk 24 Change from Baseline | 18.8 Scores on a scale | Standard Deviation 21.8 |
| Medical Management | Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline | CSS Medication Wk 52 | 62.7 Scores on a scale | Standard Deviation 27 |
Secondary
Missed Days Work/School
Time frame: 12, 24 and 52 weeks post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Missed Days Work/School | Wk 24 | 0.2 Days | Standard Deviation 0.8 |
| Balloon Sinus Dilation | Missed Days Work/School | Wk 24 Change from Baseline | -2.0 Days | Standard Deviation 4.4 |
| Balloon Sinus Dilation | Missed Days Work/School | Wk 52 | 0.4 Days | Standard Deviation 2.9 |
| Balloon Sinus Dilation | Missed Days Work/School | Wk 52 Change from Baseline | -1.5 Days | Standard Deviation 3.9 |
| Balloon Sinus Dilation | Missed Days Work/School | Baseline | 3.0 Days | Standard Deviation 9.2 |
| Medical Management | Missed Days Work/School | Wk 52 Change from Baseline | -1.2 Days | Standard Deviation 2.2 |
| Medical Management | Missed Days Work/School | Baseline | 1.4 Days | Standard Deviation 2.4 |
| Medical Management | Missed Days Work/School | Wk 24 | 0.0 Days | Standard Deviation 0 |
| Medical Management | Missed Days Work/School | Wk 52 | 0.1 Days | Standard Deviation 0.4 |
| Medical Management | Missed Days Work/School | Wk 24 Change from Baseline | -1.3 Days | Standard Deviation 2.2 |
Secondary
Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Sinus Dilation | Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure | 12 Participants |
Secondary
Number of Sinus Infections
Time frame: 24 and 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Number of Sinus Infections | Sinus Infections through 24 weeks | 0.3 Sinus infections | Standard Deviation 0.6 |
| Balloon Sinus Dilation | Number of Sinus Infections | Sinus Infections through 52 weeks | 0.5 Sinus infections | Standard Deviation 0.8 |
| Medical Management | Number of Sinus Infections | Sinus Infections through 24 weeks | 0.3 Sinus infections | Standard Deviation 0.6 |
| Medical Management | Number of Sinus Infections | Sinus Infections through 52 weeks | 0.6 Sinus infections | Standard Deviation 0.8 |
Secondary
Number of Sinus-related Medical Care Visits
Time frame: 12 weeks, 24 weeks, 52 weeks post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Number of Sinus-related Medical Care Visits | Sinus-Related Visits at Baseline | 2.0 Visits | Standard Deviation 2.1 |
| Balloon Sinus Dilation | Number of Sinus-related Medical Care Visits | Sinus-Related Visits through 12 weeks | 0.1 Visits | Standard Deviation 0.3 |
| Balloon Sinus Dilation | Number of Sinus-related Medical Care Visits | Sinus-Related Visits through 24 weeks | 0.1 Visits | Standard Deviation 0.4 |
| Balloon Sinus Dilation | Number of Sinus-related Medical Care Visits | Sinus-Related Visits through 52 weeks | 0.2 Visits | Standard Deviation 0.5 |
| Medical Management | Number of Sinus-related Medical Care Visits | Sinus-Related Visits through 52 weeks | 0.1 Visits | Standard Deviation 0.6 |
| Medical Management | Number of Sinus-related Medical Care Visits | Sinus-Related Visits at Baseline | 1.2 Visits | Standard Deviation 1.6 |
| Medical Management | Number of Sinus-related Medical Care Visits | Sinus-Related Visits through 24 weeks | 0.1 Visits | Standard Deviation 0.6 |
| Medical Management | Number of Sinus-related Medical Care Visits | Sinus-Related Visits through 12 weeks | 0.1 Visits | Standard Deviation 0.5 |
Secondary
Number of Subjects Requiring Revision for Subjects Electing BSD
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.
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Sinus Dilation | Number of Subjects Requiring Revision for Subjects Electing BSD | 3 Participants |
| Medical Management | Number of Subjects Requiring Revision for Subjects Electing BSD | 0 Participants |
Secondary
Post-operative Return to Normal Activity (RTNA)
Time frame: 2 weeks post treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinus Dilation | Post-operative Return to Normal Activity (RTNA) | 3.6 Days | Standard Deviation 4.1 |
| Medical Management | Post-operative Return to Normal Activity (RTNA) | 2.8 Days | Standard Deviation 3.7 |
| Operating Room | Post-operative Return to Normal Activity (RTNA) | 5.9 Days | Standard Deviation 4.1 |