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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Sinus Dilation | Subjects with chronic sinusitis electing to have a balloon sinus dilation |
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| Medical Management | Subjects with chronic sinusitis electing to continue with medical therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon sinus dilation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects age 19 or older with radiographically documented CRS
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| Name | Affiliation | Role |
|---|---|---|
| Spencer Payne, MD | University of Virginia | Principal Investigator |
| Christopher Melroy, MD | Georgia Nasal and Sinus Institute | Principal Investigator |
| Boris Karanfilov, MD | Ohio Sinus Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver | Colorado | United States | ||||
Publication is planned
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Sinus Dilation | Subjects with chronic sinusitis electing to have a balloon sinus dilation |
| FG001 | Medical Management | Subjects with chronic sinusitis electing to continue medical therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Medical Management | Drug | Subjects who select to continue on medical management rather than have a BSD procedure. |
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| 12, 24, and 52 weeks post treatment |
| 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). | 12, 24 and 52 weeks post treatment |
| 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. | 12 weeks, 24 weeks, 52 weeks post treatment |
| Change in Disease-specific Medication Usage | 12, 24 and 52 weeks post treatment |
| Missed Days Work/School | 12, 24 and 52 weeks post treatment |
| Number of Sinus-related Medical Care Visits | 12 weeks, 24 weeks, 52 weeks post treatment |
| Number of Sinus Infections | 24 and 52 weeks |
| 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. | 52 weeks |
| 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 |
| Miami |
| Florida |
| United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | United States |
| Savannah | Georgia | United States |
| Vidalia | Georgia | United States |
| Chicago | Illinois | United States |
| Rockford | Illinois | United States |
| South Bend | Indiana | United States |
| Louisville | Kentucky | United States |
| Neptune City | New Jersey | United States |
| Dublin | Ohio | United States |
| Frisco | Texas | United States |
| McKinney | Texas | United States |
| Plano | Texas | United States |
| Charlottesville | Virginia | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Beaver Dam | Wisconsin | United States |
| Wauwatosa | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Sinus Dilation | Subjects with chronic sinusitis electing to have a balloon sinus dilation |
| BG001 | Medical Management | Subjects with chronic sinusitis electing to continue medical therapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Chronic Sinusitis Survey (CSS) Score Change from Baseline to 24 Weeks for BSD compared to MM | Posted | Mean | Standard Deviation | Scores on a scale | 24 weeks post treatment |
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| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 12, 24, and 52 weeks post treatment |
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| 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). | Posted | Mean | Standard Deviation | Scores on a scale | 12, 24 and 52 weeks post treatment |
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| 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. | Posted | Mean | Standard Deviation | Scores on a scale | 12 weeks, 24 weeks, 52 weeks post treatment |
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| Secondary | Change in Disease-specific Medication Usage | Posted | Mean | Standard Deviation | Medications | 12, 24 and 52 weeks post treatment |
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| Secondary | Missed Days Work/School | Posted | Mean | Standard Deviation | Days | 12, 24 and 52 weeks post treatment |
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| Secondary | Number of Sinus-related Medical Care Visits | Posted | Mean | Standard Deviation | Visits | 12 weeks, 24 weeks, 52 weeks post treatment |
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| Secondary | Number of Sinus Infections | Posted | Mean | Standard Deviation | Sinus infections | 24 and 52 weeks |
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| 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. | Posted | Number | Participants | 52 weeks |
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| Secondary | Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure | Posted | Number | Participants | 52 weeks |
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| Secondary | Post-operative Return to Normal Activity (RTNA) | Posted | Mean | Standard Deviation | Days | 2 weeks post treatment |
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No AEs were related to the device
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Balloon Sinus Dilation | Subjects with chronic sinusitis electing to have a balloon sinus dilation | 1 | 146 | 6 | 146 | 49 | 146 |
| EG001 | Medical Management | Subjects with chronic sinusitis electing to continue medical therapy | 0 | 52 | 0 | 52 | 8 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Bleeding | Gastrointestinal disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Pancreatitis | Hepatobiliary disorders | Non-systematic Assessment |
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| Neuropenic Shock | Immune system disorders | Non-systematic Assessment |
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| Cancer, Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Bells Palsy, TIA | Nervous system disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| URI | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Manager | Acclarent Inc. | 949-453-6408 | PChen126@ITS.JNJ.com |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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