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This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Dilation | Active Comparator | Balloon dilation with FinESS device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RS-Series Rhinosinusitis Treatment System | Device | Single arm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of Device-related or Procedure-related Complications | Through 12 months post-procedure | |
| Patency of the Treated Area as Verified by CT Scan | Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians. | Post-treatment at 3 months |
| Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement | Symptomatic change in SNOT 20 scores on a 5-point Likert scale where "0" = no problem to "5" = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful. | Post-treatment through 12 months |
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Inclusion Criteria:
Subjects age 18 or older with chronic rhinosinusitis of the maxillary or maxillary and anterior ethmoid sinuses
A CT scan taken after maximal medical therapy (e.g., local or systemic antibiotics, topical steroids, etc.) must show one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Stankiewicz, MD | Loyola University Medical Center, Maywood, IL | Principal Investigator |
| Thomas Tami, MD | Cincinnati Sinus Institute, Cincinnati OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California Ear, Nose and Throat Medical Group | Fresno | California | 93720 | United States | ||
| NorthShore University HealthSystem |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19419611 | Derived | Stankiewicz J, Tami T, Truitt T, Atkins J, Liepert D, Winegar B. Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. Am J Rhinol Allergy. 2009 May-Jun;23(3):321-7. doi: 10.2500/ajra.2009.23.3274. Epub 2009 Jan 16. |
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All patients had transantral balloon dilation of the maxillary sinus ostium and ethmoid infundibulum with the FinESS Sinus System.
Enrolled patients with chronic rhinosinusitis (CRS) from Ear, Nose Throat (ENT) physician practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | FinESS Sisnus System Balloon Dilation | Transantral balloon dilation ofthe maxillary sinuses with the FinESS Sinus System. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| FinESS Balloon |
| Device |
|
| Evanston |
| Illinois |
| 60201 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| St. Cloud Ear, Nose & Throat - Head and Neck Clinic | Saint Cloud | Minnesota | 56303 | United States |
| Otolaryngology-Facial Plastic Surgery of Long Island P.C. | Lake Success | New York | 11042 | United States |
| Charlotte Eye, Ear, Nose & Throat Associates | Charlotte | North Carolina | 28210 | United States |
| Midwest Ear, Nose, and Throat | Sioux Falls | South Dakota | 57108 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Austin Ear, Nose & Throat Clinic | Austin | Texas | 78705-1023 | United States |
| Texas Sinus Center | Boerne | Texas | 78006 | United States |
| San Antonio Ear, Nose, and Throat Research | San Antonio | Texas | 78229 | United States |
| Ear, Nose, Throat & Plastic Surgery Associates, PS | Auburn | Washington | 98002 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Dilation |
| 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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| Region of Enrollment | Number | 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 | Incidences of Device-related or Procedure-related Complications | Patients completing 12 month follow-up | Posted | Number | participants | Through 12 months post-procedure |
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| Primary | Patency of the Treated Area as Verified by CT Scan | Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians. | Analysis of ostia patency done per protocol | Posted | Number | Ostia | Post-treatment at 3 months | Treated Maxillary Ostia | Participants |
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| Primary | Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement | Symptomatic change in SNOT 20 scores on a 5-point Likert scale where "0" = no problem to "5" = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful. | Score reduction in SNOT 20 Scale Scores. Baseline through 12 months post-procedure. | Posted | Number | Scores on a scale | Post-treatment through 12 months |
|
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12 months post-procedure
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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 | Treatment Group (ALL) | 1 | 71 | 0 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subcutaneous emphysema of the neck and upper chest | Skin and subcutaneous tissue disorders | Systematic Assessment | Continuous positive airway pressure (CPAP) usage resumed same day as procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Entellus Medical | Entellus Medical | 763-463-1599 |
| 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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