Sinusitis
Conditions
Keywords
Sinusitis
Brief summary
This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).
Detailed description
Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients. One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.
Interventions
DEVICEXprESS Balloon Device
Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
Sponsors
Entellus Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use * Willing and able to provide consent
Exclusion criteria
* Known Samter's Triad * History of primary ciliary dysfunction * History of cystic fibrosis * Known to be immunosuppressed * Hemophilia * Currently enrolled in another pre-approval investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessments | 1 month after procedure | Adverse event reporting as related to XprESS device or procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sino-Nasal Outcome Test (SNOT-20) at 1 Month | Baseline and 1 month after procedure | The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20. |
| SNOT-20 at 6 Months | Baseline and 6 months post procedure | The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20. |
| SNOT-20 at 12 Months | Baseline and 12 months post procedure | The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Sinuses Demonstrating Functional Patency | 12 months post procedure | Functional patency of the sinus ostia originally treated with XprESS was assessed by the clinical site either by visual endoscopic evidence of a clear drainage path or radiographic evidence of a completely aerated sinus at 12-month follow-up for the first 50 patients treated in the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XprESS Balloon Device XprESS Balloon Device: Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia). | 175 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Long-term Follow-up | Lost to Follow-up | 6 |
| Procedure Safety (1-Month) | Lost to Follow-up | 2 |
| Procedure Safety (1-Month) | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | XprESS Balloon Device |
|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 16.4 |
| Area of sinusitis Anterior ethmoid | 133 Participants |
| Area of sinusitis Frontal | 145 Participants |
| Area of sinusitis Maxillary | 162 Participants |
| Area of sinusitis Posterior ethmoid | 116 Participants |
| Area of sinusitis Sphenoid | 106 Participants |
| Lund-Mackay score | 6.9 units on a scale STANDARD_DEVIATION 4.6 |
| Nasal polyps | 55 Participants |
| Region of Enrollment United States | 175 participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 97 Participants |
| SNOT-20 | 2.1 units on a scale STANDARD_DEVIATION 1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 175 |
| other Total, other adverse events | 0 / 175 |
| serious Total, serious adverse events | 0 / 175 |
Outcome results
Primary
Safety Assessments
Adverse event reporting as related to XprESS device or procedure
Time frame: 1 month after procedure
Population: All enrolled participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XprESS Balloon Device | Safety Assessments | 2 Participants |
Secondary
Sino-Nasal Outcome Test (SNOT-20) at 1 Month
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
Time frame: Baseline and 1 month after procedure
Population: All participants with baseline and 1-month SNOT-20 scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XprESS Balloon Device | Sino-Nasal Outcome Test (SNOT-20) at 1 Month | Baseline | 2.1 score on a scale | Standard Deviation 1 |
| XprESS Balloon Device | Sino-Nasal Outcome Test (SNOT-20) at 1 Month | 1-Month Follow-up | 1.0 score on a scale | Standard Deviation 0.8 |
p-value: <0.0001t-test, 2 sided
Secondary
SNOT-20 at 12 Months
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
Time frame: Baseline and 12 months post procedure
Population: Participants who were enrolled in the long-term follow-up and have matching baseline and 12-month SNOT-20 scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XprESS Balloon Device | SNOT-20 at 12 Months | Baseline | 1.9 score on a scale | Standard Deviation 1.1 |
| XprESS Balloon Device | SNOT-20 at 12 Months | 12-Month Follow-up | 0.8 score on a scale | Standard Deviation 0.7 |
Secondary
SNOT-20 at 6 Months
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
Time frame: Baseline and 6 months post procedure
Population: Participants enrolled in the long-term follow-up who have matching baseline and 6-month SNOT-20 scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XprESS Balloon Device | SNOT-20 at 6 Months | Baseline | 2.0 score on a scale | Standard Deviation 1.1 |
| XprESS Balloon Device | SNOT-20 at 6 Months | 6-Month Follow-up | 0.8 score on a scale | Standard Deviation 0.7 |
p-value: <0.0001t-test, 2 sided
Other Pre-specified
Number of Sinuses Demonstrating Functional Patency
Functional patency of the sinus ostia originally treated with XprESS was assessed by the clinical site either by visual endoscopic evidence of a clear drainage path or radiographic evidence of a completely aerated sinus at 12-month follow-up for the first 50 patients treated in the study.
Time frame: 12 months post procedure
Population: Frontal and sphenoid sinuses treated with XprESS and evaluated by endoscopy or CT scan at 12 months post procedure.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| XprESS Balloon Device | Number of Sinuses Demonstrating Functional Patency | 76 Sinuses |