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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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This study evaluates long-term safety and effectiveness of primary sinus surgery in a real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using commercially available sinus instrumentation (e.g. sinus balloon catheters, powered microdebriders, manual instruments).
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completing Follow-Up Visits | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adults diagnosed by an ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) undergoing a primary transnasal endoscopic sinus surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85032 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Sinus Dilation | Subjects who underwent a balloon sinus dilation procedure |
| FG001 | Endoscopic Sinus Surgery (ESS) | Subjects who underwent a transnasal endoscopic sinus surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Los Angeles |
| California |
| 90048 |
| United States |
| Sacramento | California | 95815 | United States |
| San Francisco | California | 94108 | United States |
| Miami | Florida | 33136 | United States |
| Atlanta | Georgia | 30342 | United States |
| Evans | Georgia | 30809 | United States |
| Berwyn | Illinois | 60402 | United States |
| Chicago | Illinois | 60602 | United States |
| Fort Wayne | Indiana | 46825 | United States |
| West Burlington | Iowa | 52655 | United States |
| Alexandria | Louisiana | 71303 | United States |
| Bethesda | Maryland | 20889 | United States |
| City of Saint Peters | Missouri | 63376 | United States |
| Helena | Montana | 59601 | United States |
| Henderson | Nevada | 89052 | United States |
| Albuquerque | New Mexico | 87109 | United States |
| Long Beach | New York | 11561 | United States |
| New York | New York | 10021 | United States |
| Knoxville | Tennessee | 37934 | United States |
| Nashville | Tennessee | 37232 | United States |
| Fort Worth | Texas | 76104 | United States |
| Houston | Texas | 77098 | United States |
| McKinney | Texas | 75070 | United States |
| San Antonio | Texas | 78249 | United States |
| FG002 | Hybrid | Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Sinus Dilation | Subjects who underwent a balloon sinus dilation procedure |
| BG001 | Endoscopic Sinus Surgery (ESS) | Subjects who underwent a transnasal endoscopic sinus surgery |
| BG002 | Hybrid | Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery. |
| BG003 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Number of Participants Completing Follow-Up Visits | Due to early cancellation of the study data for this endpoint were not collected. | Posted | 2 years |
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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 (BSD) | Subjects who underwent a balloon sinus dilation procedure | 1 | 140 | 8 | 140 | ||
| EG001 | Endoscopic Sinus Surgery (ESS) | Subjects who underwent a transnasal endoscopic sinus surgery | 1 | 67 | 4 | 67 | ||
| EG002 | Hybrid | Subjects who underwent a procedure with balloon sinus dilation and transnasal endoscopic sinus surgery. | 0 | 45 | 0 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| pneumonia | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Drug hypersensitivity | Immune system disorders |
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| Hypersensitivity | Immune system disorders |
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| Folliculitis | Infections and infestations |
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| Influenza | Infections and infestations |
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| Sinusitis | Infections and infestations |
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| Migraine | Nervous system disorders |
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| Sinus headache | Nervous system disorders |
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| Anxiety | Psychiatric disorders |
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| Cough | Respiratory, thoracic and mediastinal disorders |
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| Hypertension | Vascular disorders |
| |||
| Dehiscence in the lamina papyracea | Surgical and medical procedures |
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Due to the early cancellation of the study, study results reported are limited to subject enrollment, subject demographics, and Adverse Events (SAE and Non-serious).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Chen | Acclarent, Inc | 949-453-6408 | pchen126@its.jnj.com |
| 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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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| White |
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