Rhinosinusitis
Conditions
Keywords
Rhinosinusitis, Balloon catheters, Office treatment, Otorhinolaryngologic diseases, Respiratory tract infections, Respiratory tract diseases, FinESS Sinus Treatment, Endoscopic sinus surgery
Brief summary
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
Detailed description
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office. Also to demonstrate the long-term durability of FinESS Sinus Treatment performed in an office setting.
Interventions
DEVICEFinESS Sinus Treatment
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 or older * Male or female subjects * Diagnosis of rhinosinusitis (CT radiographic evidence and medical evaluation) * Willing to comply with protocol requirements * Able to provide consent
Exclusion criteria
* Hemophilia * Cystic fibrosis * Ciliary dysfunction * Severe septal deviation causing obstruction of the ostiomeatal unit * Pregnant females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sino-Nasal Outcomes Test | Baseline and 12 months post procedure | The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated, disease-specific patient-reported instrument designed to indicate the severity of rhinosinusitis symptoms. The SNOT-20 evaluates 20 symptoms on a scale from 0 (no problem) to 5 (problem as bad as it can be). The overall SNOT-20 score is the average of the 20 symptoms scores providing a range from 0 to 5 with higher scores indicating worse symptoms. The minimal clinically important difference (MCID) has been determined to be a reduction of 0.8 or more in the overall SNOT-20 score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain | Baseline and 12 months post procedure | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with 0 indicating no symptoms and 5 indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. |
| Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain | Baseline and 12 months post procedure | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with 0 indicating no symptoms and 5 indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. |
| Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain | Baseline and 12 months post procedure | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with 0 indicating no symptoms and 5 indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. |
| Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain | Baseline and 12 months post procedure | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with 0 indicating no symptoms and 5 indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. |
| Number of Participants Using Antihistamines | Baseline and 12 months post procedure | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months. |
| Number of Participants Using Antibiotics | Baseline and 12 months post procedure | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months. |
| Number of Participants With Device and/or Procedure-related Adverse Events | Baseline through 12 months post procedure | Number of participants with 1 or more adverse events considered possibly or definitely related to the FinESS device and/or balloon dilation procedure. |
| Number of Participants Using Nasal Steroids | Baseline and 12 months post procedure | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balloon Dilation Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device. | 69 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Unable to access sinus with device | 5 |
Baseline characteristics
| Characteristic | Balloon Dilation |
|---|---|
| Affected sinuses Maxillary and anterior ethmoid | 14 Participants |
| Affected sinuses Maxillary only | 55 Participants |
| Age, Continuous | 47.1 years STANDARD_DEVIATION 14.4 |
| Previous sinus surgery | 7 Participants |
| Region of Enrollment United States | 69 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 74 |
| other Total, other adverse events | 9 / 74 |
| serious Total, serious adverse events | 0 / 74 |
Outcome results
Primary
Sino-Nasal Outcomes Test
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated, disease-specific patient-reported instrument designed to indicate the severity of rhinosinusitis symptoms. The SNOT-20 evaluates 20 symptoms on a scale from 0 (no problem) to 5 (problem as bad as it can be). The overall SNOT-20 score is the average of the 20 symptoms scores providing a range from 0 to 5 with higher scores indicating worse symptoms. The minimal clinically important difference (MCID) has been determined to be a reduction of 0.8 or more in the overall SNOT-20 score.
Time frame: Baseline and 12 months post procedure
Population: All treated participants with baseline and 12-month SNOT-20 scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Dilation | Sino-Nasal Outcomes Test | Baseline | 2.3 score on a scale | Standard Deviation 0.9 |
| Balloon Dilation | Sino-Nasal Outcomes Test | 12-Month follow-up | 1.1 score on a scale | Standard Deviation 1 |
p-value: <0.0001t-test, 2 sided
Secondary
Number of Participants Using Antibiotics
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months.
Time frame: Baseline and 12 months post procedure
Population: All treated participants with baseline and 12-month RSI scores. Four participants with blank responses at either interval are considered not evaluable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Dilation | Number of Participants Using Antibiotics | Baseline | 5.5 number of antibiotic courses | Standard Deviation 2.5 |
| Balloon Dilation | Number of Participants Using Antibiotics | 12-Month Follow-up | 2.3 number of antibiotic courses | Standard Deviation 2.4 |
p-value: <0.0001t-test, 2 sided
Secondary
Number of Participants Using Antihistamines
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months.
Time frame: Baseline and 12 months post procedure
Population: All treated participants with baseline and 12-month RSI scores.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balloon Dilation | Number of Participants Using Antihistamines | Baseline | 33 Participants |
| Balloon Dilation | Number of Participants Using Antihistamines | 12-Month Follow-up | 28 Participants |
p-value: 0.292t-test, 2 sided
Secondary
Number of Participants Using Nasal Steroids
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months.
Time frame: Baseline and 12 months post procedure
Population: All treated participants with baseline and 12-month RSI scores.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Balloon Dilation | Number of Participants Using Nasal Steroids | Baseline | 47 Participants |
| Balloon Dilation | Number of Participants Using Nasal Steroids | 12-Month Follow-up | 36 Participants |
p-value: 0.009t-test, 2 sided
Secondary
Number of Participants With Device and/or Procedure-related Adverse Events
Number of participants with 1 or more adverse events considered possibly or definitely related to the FinESS device and/or balloon dilation procedure.
Time frame: Baseline through 12 months post procedure
Population: All enrolled participants. Participants with unsuccessful procedures (sinus could not be accessed and dilated) were followed for 1 week post procedure. Treated participant are evaluated through 12 months post procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balloon Dilation | Number of Participants With Device and/or Procedure-related Adverse Events | 16 Participants |
Secondary
Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with 0 indicating no symptoms and 5 indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.
Time frame: Baseline and 12 months post procedure
Population: All treated participants with baseline and 12-month RSI scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Dilation | Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain | Baseline | 61.4 score on a scale | Standard Deviation 24 |
| Balloon Dilation | Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain | 12-Month Follow-up | 24.4 score on a scale | Standard Deviation 23.9 |
p-value: <0.0001t-test, 2 sided
Secondary
Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with 0 indicating no symptoms and 5 indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.
Time frame: Baseline and 12 months post procedure
Population: All treated participants with baseline and 12-month RSI scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Dilation | Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain | Baseline | 53.7 score on a scale | Standard Deviation 23.9 |
| Balloon Dilation | Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain | 12-Month Follow-up | 20.7 score on a scale | Standard Deviation 21.1 |
p-value: <0.0001t-test, 2 sided
Secondary
Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with 0 indicating no symptoms and 5 indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.
Time frame: Baseline and 12 months post procedure
Population: All treated participants with baseline and 12-month RSI scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Dilation | Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain | Baseline | 40.6 score on a scale | Standard Deviation 20.3 |
| Balloon Dilation | Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain | 12-Month Follow-up | 15.4 score on a scale | Standard Deviation 15.9 |
p-value: <0.0001t-test, 2 sided
Secondary
Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain
The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with 0 indicating no symptoms and 5 indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms.
Time frame: Baseline and 12 months post procedure
Population: All treated participants with baseline and 12-month RSI scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Dilation | Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain | Baseline | 40.6 score on a scale | Standard Deviation 22.4 |
| Balloon Dilation | Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain | 12-Month Follow-up | 15.4 score on a scale | Standard Deviation 18.6 |
p-value: <0.0001t-test, 2 sided