Chronic Sinusitis
Conditions
Brief summary
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
Interventions
DEVICERelieva™ Balloon Sinuplasty™ System
Balloon dilation will be performed using endoscopic equipment with video documentation capability.
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 2 and \< 18 years 2. Both male and female patients eligible 3. Planned surgical intervention (i.e. endoscopic sinus surgery, adenoidectomy, sinus irrigation for obtaining a culture) recommended by PI, consented to by patient's legal guardian) 4. Longstanding sinusitis: \>3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan
Exclusion criteria
1. Extensive previous sinonasal surgery in target ostia 2. Cystic fibrosis 3. Extensive sinonasal osteoneogenesis 4. Sinonasal tumors or obstructive lesions 5. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium 6. Ciliary dysfunction 7. For female patients of childbearing age: the patient is either pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months | 12 months | Number of device-related adverse events from time of procedure through 12 months post-procedure. |
| Effectiveness: Change in Sinus Symptom Scores (SN-5) | 12 months | Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement. |
| Effectiveness: Change in Sinus Symptom Scores (SNOT-20) | 12 months | Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success: Ability to Access/Dilate Sinus Ostia | 12 months | Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted. |
| Effectiveness: Medication Thru 1 yr | 12 months | Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation. |
| Effectiveness of Dilation/Measured by Post-op Interventions | 12 months | Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported. |
| Days Out of School During the 12 Months of Follow-up | 12 months | Quantitative assessment of days out of school during the 12 months of follow-up. |
| Revision Rate | at 1 year | The number of subjects requiring revisions out of 33 subjects treated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balloon Device Balloon catheter dilation of sinus ostia | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Balloon Device |
|---|---|
| Age, Categorical <=18 years | 44 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 8.14 years STANDARD_DEVIATION 3.99 |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Effectiveness: Change in Sinus Symptom Scores (SN-5)
Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.
Time frame: 12 months
Population: Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinuplasty Treatment | Effectiveness: Change in Sinus Symptom Scores (SN-5) | 2.00 change in SN-5 score | Standard Deviation 1.4 |
Primary
Effectiveness: Change in Sinus Symptom Scores (SNOT-20)
Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.
Time frame: 12 months
Population: Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinuplasty Treatment | Effectiveness: Change in Sinus Symptom Scores (SNOT-20) | 0.95 change in SNOT-20 score | Standard Deviation 0.51 |
Primary
Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months
Number of device-related adverse events from time of procedure through 12 months post-procedure.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Sinuplasty Treatment | Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months | 0 number of events |
Secondary
Days Out of School During the 12 Months of Follow-up
Quantitative assessment of days out of school during the 12 months of follow-up.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinuplasty Treatment | Days Out of School During the 12 Months of Follow-up | 5.75 days | Standard Deviation 7.46 |
Secondary
Device Success: Ability to Access/Dilate Sinus Ostia
Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.
Time frame: 12 months
Population: intent to treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Sinuplasty Treatment | Device Success: Ability to Access/Dilate Sinus Ostia | 90.9 percentage of sinuses successful |
Secondary
Effectiveness: Medication Thru 1 yr
Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Sinuplasty Treatment | Effectiveness: Medication Thru 1 yr | 68.3 percentage of participants |
Secondary
Effectiveness of Dilation/Measured by Post-op Interventions
Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Sinuplasty Treatment | Effectiveness of Dilation/Measured by Post-op Interventions | 0 number of interventions |
Secondary
Revision Rate
The number of subjects requiring revisions out of 33 subjects treated.
Time frame: at 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Sinuplasty Treatment | Revision Rate | 2 participants |