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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| balloon sinus dilation | Active Comparator | Balloon sinus dilation will be conducted in-office under local anesthesia. |
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| medical therapy | Active Comparator | Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balloon sinus dilation | Device |
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| |
| medical therapy |
| Measure | Description | Time Frame |
|---|---|---|
| CSS Total Score Change From Baseline to 24 Week Visit | The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include "0 Weeks" (minimum), "1-2 Weeks", "3-4 Weeks", "5-6 Weeks", and "7-8 Weeks" (maximum). The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes. The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only. 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 Week Visit |
| Measure | Description | Time Frame |
|---|---|---|
| CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("0 Weeks" (minimum) to "7-8 Weeks" (maximum)) 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 severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated 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 over 24 and 48 weeks, and average total CSS score over 48 weeks for subjects randomized to BSD versus medical management. Higher score indicates greater improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Sikand, MD | Ear Nose and Throat Consultants of Nevada | Principal Investigator |
| Ford Albritton, MD | Texas Institute for Sinus & Respiratory Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35242 | United States | |||
Publication planned in the future
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Sinus Dilation | Subjects treated with balloon sinus dilation |
| FG001 | Medical Therapy | Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Other |
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| 8, 16, 24, 32, 40, and 48 Weeks |
| RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | 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 include "Never" (minimum), "Almost Never", "Sometimes", "Almost Always", "Always" (maximum). RSDI scores range from 0 to 120. Subscores are averaged 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 8, 24 and 48 weeks for subjects randomized to BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease). | 8, 24, and 48 Weeks |
| Medication Usage at 24 and 48 Weeks | Comparison of medication usage at 24 and 48 weeks (days oral antibiotics, oral steroids, topical intranasal steroid sprays, and 'atypical' topical steroids (drops or respules)) for subjects randomized to BSD versus medical management. | 24 Weeks and 48 Weeks |
| Unscheduled Medical Care Visits Due to Sinusitis | Comparison of unscheduled medical care visits due to sinusitis at 24 and 48 weeks for subjects randomized to BSD versus medical management. | 24 Weeks and 48 Weeks |
| Sinus Infections and Sinus Severity - Part 1 | Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management. | 24 Weeks and 48 Weeks |
| Sinus Infections and Sinus Severity - Part 2 | Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management. | 24 Weeks |
| Frequency of Second Procedure | Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure. | Up to 24 weeks |
| Return to Normal Activity | Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure | 2 week |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Las Vegas | Nevada | 89113 | United States |
| Dallas | Texas | 75231 | United States |
| McKinney | Texas | 75070 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Sinus Dilation | Subjects treated with balloon sinus dilation |
| BG001 | Medical Therapy | Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | CSS Total Score Change From Baseline to 24 Week Visit | The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include "0 Weeks" (minimum), "1-2 Weeks", "3-4 Weeks", "5-6 Weeks", and "7-8 Weeks" (maximum). The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes. The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only. 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. | Posted | Mean | Standard Deviation | scores on a scale | 24 Week Visit |
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| Secondary | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("0 Weeks" (minimum) to "7-8 Weeks" (maximum)) 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 severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated 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 over 24 and 48 weeks, and average total CSS score over 48 weeks for subjects randomized to BSD versus medical management. Higher score indicates greater improvement. | All available date for each follow-up visit is presented. | Posted | Mean | Standard Deviation | scores on a scale | 8, 16, 24, 32, 40, and 48 Weeks |
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| Secondary | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | 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 include "Never" (minimum), "Almost Never", "Sometimes", "Almost Always", "Always" (maximum). RSDI scores range from 0 to 120. Subscores are averaged 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 8, 24 and 48 weeks for subjects randomized to BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease). | All available data for each follow-up visit is presented. | Posted | Mean | Standard Deviation | scores on a scale | 8, 24, and 48 Weeks |
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| Secondary | Medication Usage at 24 and 48 Weeks | Comparison of medication usage at 24 and 48 weeks (days oral antibiotics, oral steroids, topical intranasal steroid sprays, and 'atypical' topical steroids (drops or respules)) for subjects randomized to BSD versus medical management. | All available data for each follow-up visit is presented. | Posted | Mean | Standard Deviation | Days | 24 Weeks and 48 Weeks |
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| Secondary | Unscheduled Medical Care Visits Due to Sinusitis | Comparison of unscheduled medical care visits due to sinusitis at 24 and 48 weeks for subjects randomized to BSD versus medical management. | All available data for each follow-up visit is presented. | Posted | Mean | Standard Deviation | Medical care visits | 24 Weeks and 48 Weeks |
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| Secondary | Sinus Infections and Sinus Severity - Part 1 | Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management. | All available data for each follow-up visit is presented. | Posted | Mean | Standard Deviation | Sinus Infections | 24 Weeks and 48 Weeks |
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| Secondary | Sinus Infections and Sinus Severity - Part 2 | Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management. | All available data for each follow-up visit is presented. | Posted | Count of Participants | Participants | 24 Weeks |
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| Secondary | Frequency of Second Procedure | Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure. | Posted | Count of Participants | Participants | Up to 24 weeks |
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| Secondary | Return to Normal Activity | Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure | Posted | Mean | Standard Deviation | Days | 2 week |
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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 treated with balloon sinus dilation | 0 | 29 | 1 | 29 | 17 | 29 |
| EG001 | Medical Therapy | Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement. | 0 | 30 | 0 | 30 | 18 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations |
| |||
| Headache | Nervous system disorders |
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| Sinusitis | Infections and infestations |
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| Upper Respiratory Infection | Infections and infestations |
| |||
| Dental abcess | Infections and infestations |
| |||
| Hyposmia | Respiratory, thoracic and mediastinal disorders |
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| Pneumonia, aspiration | Infections and infestations |
| |||
| Cervical Lymphadenopathy | Immune system disorders |
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| Eustachian Tube Dysfunction | Ear and labyrinth disorders |
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| Pyrexia | General disorders |
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| Infertility | Reproductive system and breast disorders |
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| Gastroesophageal reflux | Gastrointestinal disorders |
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| Hernia, abdominal | Musculoskeletal and connective tissue disorders |
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| Nasal Fracture | Injury, poisoning and procedural complications |
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| Mononucleosis | Infections and infestations |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
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| Nausea | Injury, poisoning and procedural complications |
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| Nodules of Vocal Code | Respiratory, thoracic and mediastinal disorders |
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| Migraine, ocular | Nervous system disorders |
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| Poison Ivy rash | Skin and subcutaneous tissue disorders |
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| Arthritis, Psoriatic | Musculoskeletal and connective tissue disorders |
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| Rhinitis Medicamentosa | Respiratory, thoracic and mediastinal disorders |
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| Gastroenteritis | Gastrointestinal disorders |
| |||
| Pharyngitis | Infections and infestations |
| |||
| Vasovagal Reaction | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Chen | Acclarent, Inc | 949-453-6408 | pchen126@its.jnj.com |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units |
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| Counts |
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| Participants |
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| Title |
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| Denominators |
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| Categories |
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| No Change |
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| Worse |
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