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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.
Sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world. Patients suffer from headache, facial discomfort, nasal congestion, nasal drainage, loss of the sense of smell and malaise. Sinusitis is responsible for major healthcare expenditure and loss of workplace productivity.
The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal, Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure. Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinuplasty | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sinuses With Patency of Sinus Ostium After Sinuplasty | Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved. | 24 weeks |
| Number of Participants With Adverse Events Following Sinuplasty Procedure | Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Relief of Sinus Symptoms | To gain general insight into the ability of balloon catheter sinus ostial dilation to relieve sinus symptoms, scores from the pre-operative SNOT-20 evaluations were compared to scores from the post-procedure SNOT-20 evaluations at 24 weeks following the procedure. The number of participants who showed aggregate symptom relief are recorded here as having been successfully treated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Church, MD | Loma Linda University | Principal Investigator |
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Recruited from 3/2005 to 12/2005 in physician practice
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Dilation of Sinus Ostia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Dilation of Sinus Ostia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Sinuses With Patency of Sinus Ostium After Sinuplasty | Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved. | Analysis per Protocol; based on all sinuses of subjects not lost to follow-up at 24 weeks | Posted | Number | Sinuses | 24 weeks | sinuses | sinuses |
|
|
6 months
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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 Dilation of Sinus Ostia |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bacterial sinusitis | General disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura England, Manager-Clinical Affairs | Acclarent | 650-687-4466 | lenglan1@its.jnj.com |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| Week 24 |
| Participants |
|
| 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 |
|
| sinuses |
|
|
| Primary | Number of Participants With Adverse Events Following Sinuplasty Procedure | Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up). | Analysis per protocol; based on subjects not lost to follow-up at 24 weeks | Posted | Number | Participants | 24 weeks |
|
|
|
| Secondary | Number of Participants Experiencing Relief of Sinus Symptoms | To gain general insight into the ability of balloon catheter sinus ostial dilation to relieve sinus symptoms, scores from the pre-operative SNOT-20 evaluations were compared to scores from the post-procedure SNOT-20 evaluations at 24 weeks following the procedure. The number of participants who showed aggregate symptom relief are recorded here as having been successfully treated. | All patients treated per protocol; includes all subjects not lost to follow-up at 24 weeks and who completed symptom questionnaire | Posted | Number | Participants | Week 24 |
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| 0 |
| 109 |
| 9 |
| 109 |
If requested by Sponsor, Investigator(s) shall delay the submission of any publication or presentation for up to sixty (60) days from the date of Sponsor's request to permit the preparation and filing of related patent applications by Sponsor or for Sponsor to take other steps to protect its intellectual property interests.
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |