Sinusitis
Conditions
Keywords
sinus infections, sinusitis, chronic sinusitis, rhinosinusitis, allergic sinusitis, allergic rhinitis, chronic rhinosinusitis, sinus disease in children, sinus balloon dilation, balloon dilatation, sinus disease, pediatric
Brief summary
Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.
Interventions
DEVICEXprESS device and PathAssist confirmation tools
Sponsors
Entellus Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.
Exclusion criteria
History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success: Sinuses Successfully Treated With Balloon Dilation | Index procedure | Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus. |
| Complications | Index procedure through 3-month follow-up | Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life From Baseline Through Completion | Baseline to 6-month follow-up | Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score. |
| Number of Subjects Who Undergo a Revision or Additional Surgery During the Study | Procedure-6 month follow up | Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported |
Countries
United States
Participant flow
Recruitment details
Sequential enrollment of eligible participants at sites.
Participants by arm
| Arm | Count |
|---|---|
| Balloon Sinus Dilation Balloon Sinus Dilation using XprESS and PathAssist Devices. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Balloon Sinus Dilation |
|---|---|
| Age, Continuous | 9.7 years STANDARD_DEVIATION 4.9 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Complications
Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.
Time frame: Index procedure through 3-month follow-up
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Sinus Dilation | Complications | 0 participants |
Primary
Technical Success: Sinuses Successfully Treated With Balloon Dilation
Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.
Time frame: Index procedure
Population: All sinus dilations attempted in all participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Sinus Dilation | Technical Success: Sinuses Successfully Treated With Balloon Dilation | 157 sinus dilation attempts |
Secondary
Change in Quality of Life From Baseline Through Completion
Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score.
Time frame: Baseline to 6-month follow-up
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinus Dilation | Change in Quality of Life From Baseline Through Completion | -2.9 Units on a scale | Standard Deviation 1.4 |
p-value: <0.0001t-test, 2 sided
Secondary
Number of Subjects Who Undergo a Revision or Additional Surgery During the Study
Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported
Time frame: Procedure-6 month follow up
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balloon Sinus Dilation | Number of Subjects Who Undergo a Revision or Additional Surgery During the Study | 0 Participants |