Chronic Sinusitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFESS instruments with or without balloon treatment
Intervention with metal instruments with or without balloon treatment
DEVICEBalloon Sinuplasty
Balloon dilatation of sinuses
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years and greater 2. Both male and female patients eligible 3. Diagnosis of chronic sinusitis that is not responsive to medical management (\> 12 weeks of symptoms and failed at least 3 to 6 weeks of appropriate antibiotic therapy as evidenced by presence of disease on CT scan) 4. Planned endoscopic sinus surgery (recommended by investigator, consented to by patient)
Exclusion criteria
1. Cystic fibrosis 2. Samter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis) 3. Sinonasal tumors or obstructive lesions 4. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium 5. Ciliary dysfunction 6. Pregnant females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline | 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks] | 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. |
| Proportion of Participants Rating Procedure as Tolerable (IO Only) | Day 0 | 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. |
| Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only) | Day 0 | 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. |
| Proportion of Participants With Revisions (IO Only) | 52 weeks | 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. |
| Mean Number of Debridements Per Participant (IO Only) | 52 weeks | 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. |
| Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline | 1 week | 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. |
| Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline | 4 weeks | 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. |
| Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline | 52 weeks | 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. |
| Proportion of Participants With Post-operative Sinus Infections | 52 weeks | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Office Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device. | 37 |
| Operating Room Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices. | 35 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Office | Operating Room | Total |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 12.5 | 47.5 years STANDARD_DEVIATION 15.1 | 51.2 years STANDARD_DEVIATION 14.2 |
| Region of Enrollment United States | 37 participants | 35 participants | 72 participants |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 37 | 1 / 35 |
| serious Total, serious adverse events | 0 / 37 | 0 / 35 |
Outcome results
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.
Time frame: 24 weeks
Population: Eleven (11) In-Office subjects and 10 Operating Room subjects were missing data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Office | Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline | -1.25 scores on a scale | Standard Deviation 0.99 |
| Operating Room | Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline | -1.35 scores on a scale | Standard Deviation 1.12 |
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.
Time frame: 24 weeks
Population: Eight (8) In-Office subjects and 15 Operating Room subjects were missing data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Office | Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks] | -3.83 Scores on a scale | Standard Deviation 4.08 |
| Operating Room | Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks] | -5.65 Scores on a scale | Standard Deviation 5.27 |
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.
Time frame: 1 week
Population: Five (5) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Office | Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline | -0.98 scores on a scale | Standard Deviation 0.79 |
| Operating Room | Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline | -0.71 scores on a scale | Standard Deviation 1.07 |
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.
Time frame: 4 weeks
Population: Six (6) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Office | Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline | -1.32 scores on a scale | Standard Deviation 0.89 |
| Operating Room | Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline | -1.21 scores on a scale | Standard Deviation 1.12 |
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.
Time frame: 52 weeks
Population: Sixteen (16) In-Office subjects and 24 Operating Room subjects were missing data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Office | Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline | -1.43 scores on a scale | Standard Deviation 0.96 |
| Operating Room | Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline | -1.10 scores on a scale | Standard Deviation 1.05 |
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.
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Office | Mean Number of Debridements Per Participant (IO Only) | 0.42 debridements | Standard Deviation 0.51 |
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.
Time frame: Day 0
Population: Eight (8) In-Office subjects were missing data for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Office | Proportion of Participants Rating Procedure as Tolerable (IO Only) | 27 participants |
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.
Time frame: Day 0
Population: One (1) In-Office subject was missing data for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Office | Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only) | 24 participants |
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).
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Office | Proportion of Participants With Post-operative Sinus Infections | 13 participants |
| Operating Room | Proportion of Participants With Post-operative Sinus Infections | 12 participants |
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.
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Office | Proportion of Participants With Revisions (IO Only) | 1 participants |