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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.
In this study, endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with the balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices. Both primary treatment of sinusitis as well as revision of previously treated sinuses will be allowed. Resource absorption will be evaluated for both venues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FESS in OR with or without balloons | Active Comparator | Functional Endoscopy Sinus Surgery |
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| Balloon sinuplasty in physician office | Active Comparator | Balloon Sinuplasty in physician office using Acclarent devices |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FESS instruments with or without balloon treatment | Device | Intervention with metal instruments with or without balloon treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline | 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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks] | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Levine, MD | Rockside Road Surgery Center Independence, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockside Road Surgery Center | Independence | Ohio | 44131 | United States |
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Eligible patients presenting to the study sites (medical clinics) for whom endoscopic sinus surgery was recommended were offered the opportunity to participate in the study by study investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | In Office | Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device. |
| FG001 | Operating Room | Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Office | Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device. |
| BG001 | Operating Room | Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices. |
| 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 |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks] | 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. | Eight (8) In-Office subjects and 15 Operating Room subjects were missing data for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | 24 weeks |
|
1 year
Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting.
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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 | Office | Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Acclarent, Inc. | 650-687-5888 | lenglan1@its.jnj.com |
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| Balloon Sinuplasty | Device | Balloon dilatation of sinuses |
|
| 24 weeks |
| Proportion of Participants Rating Procedure as Tolerable (IO Only) | Participants evaluated the tolerability of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'not tolerated' and '5' represented 'highly tolerable'. Scores of 3 through 5 were consdered tolerable ratings. The endpoint reports the proportion of participants rating the procedure as tolerable. | Day 0 |
| Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only) | Participants evaluated the per-procedural pain of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'no pain' and '5' represented 'intense pain'. Scores of 0 through 2 were considered ratings of no pain or pain of low intensity. The endpoint reports the proportion of participants reporting no pain or pain of low intensity. | Day 0 |
| Mean Number of Debridements Per Participant (IO Only) | A debridement is a procedure to remove post-surgical crusts, mucus, and fibrin from obstructed nasal and sinus cavities after functional endoscopic sinus surgery. Each physician visit in which a debridement was performed was counted as one debridement. | 52 weeks |
| Proportion of Participants With Revisions (IO Only) | After sinus surgery, the patient may require a subsequent sinus procedure (a revision procedure) to address recurrence of disease. These revision procedures are assessed in this outcome measure. | 52 weeks |
| Proportion of Participants With Post-operative Sinus Infections | Investigators reported the sinus infections as secondary to chronic rhinosinusitis (CRS) or other pre-existing conditions such as allergies. The rates of these sinus infections are consistent with the disease burden of the subjects and consistent with post procedure symptomatology associated with endoscopic sinus surgery (ESS). | 52 weeks |
| Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline | 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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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. | 1 week |
| Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline | 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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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. | 4 weeks |
| Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline | 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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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. | 52 weeks |
| BG002 | Total | Total of all reporting groups |
| 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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Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
| OG001 | Operating Room | Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices. |
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| Secondary | Proportion of Participants Rating Procedure as Tolerable (IO Only) | Participants evaluated the tolerability of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'not tolerated' and '5' represented 'highly tolerable'. Scores of 3 through 5 were consdered tolerable ratings. The endpoint reports the proportion of participants rating the procedure as tolerable. | Eight (8) In-Office subjects were missing data for this outcome measure. | Posted | Number | participants | Day 0 |
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| Secondary | Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only) | Participants evaluated the per-procedural pain of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'no pain' and '5' represented 'intense pain'. Scores of 0 through 2 were considered ratings of no pain or pain of low intensity. The endpoint reports the proportion of participants reporting no pain or pain of low intensity. | One (1) In-Office subject was missing data for this outcome measure. | Posted | Number | participants | Day 0 |
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| Secondary | Mean Number of Debridements Per Participant (IO Only) | A debridement is a procedure to remove post-surgical crusts, mucus, and fibrin from obstructed nasal and sinus cavities after functional endoscopic sinus surgery. Each physician visit in which a debridement was performed was counted as one debridement. | Posted | Mean | Standard Deviation | debridements | 52 weeks |
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| Secondary | Proportion of Participants With Revisions (IO Only) | After sinus surgery, the patient may require a subsequent sinus procedure (a revision procedure) to address recurrence of disease. These revision procedures are assessed in this outcome measure. | Posted | Number | participants | 52 weeks |
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| Secondary | Proportion of Participants With Post-operative Sinus Infections | Investigators reported the sinus infections as secondary to chronic rhinosinusitis (CRS) or other pre-existing conditions such as allergies. The rates of these sinus infections are consistent with the disease burden of the subjects and consistent with post procedure symptomatology associated with endoscopic sinus surgery (ESS). | Posted | Number | participants | 52 weeks |
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| Secondary | Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline | 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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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. | Five (5) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure. | Posted | Mean | Standard Deviation | scores on a scale | 1 week |
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| Secondary | Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline | 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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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. | Six (6) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure. | Posted | Mean | Standard Deviation | scores on a scale | 4 weeks |
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| Secondary | Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline | 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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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. | Sixteen (16) In-Office subjects and 24 Operating Room subjects were missing data for this outcome measure. | Posted | Mean | Standard Deviation | scores on a scale | 52 weeks |
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| Primary | Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline | 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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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. | Eleven (11) In-Office subjects and 10 Operating Room subjects were missing data for this outcome measure. | Posted | Mean | Standard Deviation | scores on a scale | 24 weeks |
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| 0 |
| 37 |
| 1 |
| 37 |
| EG001 | Operating Room | Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices. | 0 | 35 | 1 | 35 |
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| Swallowed pledget | Gastrointestinal disorders | Systematic Assessment | Adverse event assessment by physician according to defined follow-up visit schedule, and by patient self-reporting. |
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