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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon catheter device | Dilation of sinuses using Relieva Balloon Sinuplasty System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relieva Balloon Sinuplasty System | Device | Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intra-patient Change in SNOT-20 Score | Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5. | Baseline and 24 weeks |
| Mean Intra-patient Change in Lund-Mackay CT Scan Score | Change in Lund-Mackay CT score for paired baseline and 24 week data. The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden. | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Tolerability | Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable. | Day 0 (Day of Procedure) |
| Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects with diagnosis of CRS and planned endoscopic sinus surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Sillers, MD | Alabama Alabama Nasal and Sinus Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23136057 | Derived | Karanfilov B, Silvers S, Pasha R, Sikand A, Shikani A, Sillers M; ORIOS2 Study Investigators. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013 May;3(5):404-11. doi: 10.1002/alr.21112. Epub 2012 Nov 7. |
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The lead-in cohort (N=36) consisted of each investigator's first cases where all targeted sinuses were successfully dilated (minimum of 3 cases) with the exception of 4 investigators who participated in the prior ORIOS study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Device | Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Catheter Device | Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for sinus dilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Intra-patient Change in SNOT-20 Score | Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5. | The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 113 subjects. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 24 weeks |
|
1 year
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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 Device | Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pneumonia occurred approximately 2 months after the procedure. Related to a pre-existing condition. Not device or procedure-related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peri-orbital edema | Eye disorders | Systematic Assessment | Procedure-related. Not device related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Acclarent, Inc. | 650-687-5888 | lenglan1@its.jnj.com |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary |
| Day 0 (Day of Procedure) |
| Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events. | Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events. | Day 0 (Day of Procedure) |
| Mean Number of Days to Return to Normal Activities | Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living | 2 weeks |
| Las Vegas |
| Nevada |
| United States |
| Dublin | Ohio | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Balloon Device |
Dilation of sinuses using balloon catheter tools Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses |
|
|
| Secondary | Procedure Tolerability | Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable. | Not all subjects were compliant will filling out tolerability questionnaires. Data are available for 198 subjects. | Posted | Number | number of participants | Day 0 (Day of Procedure) |
|
|
|
| Secondary | Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary | Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary | Posted | Number | number of sinuses | Day 0 (Day of Procedure) | sinuses | sinuses |
|
|
|
| Secondary | Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events. | Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events. | Posted | Number | number of sinuses | Day 0 (Day of Procedure) | sinuses | sinuses |
|
|
|
| Secondary | Mean Number of Days to Return to Normal Activities | Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living | Not all subjects were compliant with reporting the Number of Days to Return to Normal Activities post procedure. Data are available for 181 subjects. | Posted | Mean | Standard Deviation | days | 2 weeks |
|
|
|
| Primary | Mean Intra-patient Change in Lund-Mackay CT Scan Score | Change in Lund-Mackay CT score for paired baseline and 24 week data. The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden. | The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 111 subjects. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 24 weeks |
|
|
|
| 1 |
| 203 |
| 44 |
| 203 |
|
|
| Sinus Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not device or procedure-related |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment | Not device or procedure related |
|
| Sensorineural Hearing Loss | Ear and labyrinth disorders | Systematic Assessment | Not device or procedure related |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment | Not device or procedure-rleated |
|
| Allergic reaction to medication (antibiotic) | Immune system disorders | Systematic Assessment | Not device or procedure-related |
|
| Facial Pain | General disorders | Systematic Assessment | Not device or procedure-related |
|
| Headache | General disorders | Systematic Assessment | Not device or procedure-related |
|
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |