Sinusitis
Conditions
Keywords
Sinusitis, Sinus balloon dilation patients
Brief summary
The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.
Detailed description
This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).
Interventions
DEVICEXprESS Multi-Sinus Dilation Tool
Sinus balloon dilation
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
1. Be at least age 18 years old or older. 2. Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use. 3. Have a sinus CT scan within 12 months of the procedure date. 4. Be able and willing to provide consent. 5. Be willing to comply with the protocol requirements.
Exclusion criteria
1. Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy). 2. Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure. 3. Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment. 4. Have presence of features consistent with sinus fungal disease. 5. Be allergic to nickel or barium sulfate. 6. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SNOT-20 Score | Baseline and 1-year post procedure | The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revision Sinus Surgery | 1-year post procedure | The number of participants who require revision sinus surgery to address continuing sinus symptoms. |
| Number of Participants With Serious Device and/or Procedure-related Adverse Events | Through 1-year post procedure follow-up | Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balloon Sinus Dilation Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Treatment not completed | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Balloon Sinus Dilation |
|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 16.7 |
| Baseline SNOT-20 score | 2.27 units on a scale STANDARD_DEVIATION 0.92 |
| Region of Enrollment United States | 82 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 35 Participants |
| Type of sinusitis Chronic rhinosinusitis | 73 Participants |
| Type of sinusitis Recurrent acute rhinosinusitis | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 82 |
| other Total, other adverse events | 0 / 82 |
| serious Total, serious adverse events | 1 / 82 |
Outcome results
Primary
Change in SNOT-20 Score
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.
Time frame: Baseline and 1-year post procedure
Population: All participants who had 1 or more sinuses successfully treated with the XprESS device and both baseline and 1-year follow-up SNOT-20 scores available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Change in SNOT-20 Score | Baseline | 2.3 score on a scale | Standard Deviation 0.92 |
| Balloon Sinus Dilation | Change in SNOT-20 Score | 1-Year follow-up | 0.7 score on a scale | Standard Deviation 0.75 |
Comparison: Study sample size was established to test the hypothesis that the mean SNOT-20 score is reduced by at least 0.8 points from baseline to 1 year post procedure. Using this delta, a 1-sided alpha of 0.25, and 90% power, a sample size of 19 participants was adequate to test the hypothesis.p-value: <0.0001t-test, 2 sided
Secondary
Number of Participants With Serious Device and/or Procedure-related Adverse Events
Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.
Time frame: Through 1-year post procedure follow-up
Population: All enrolled participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balloon Sinus Dilation | Number of Participants With Serious Device and/or Procedure-related Adverse Events | 0 Participants |
Secondary
Revision Sinus Surgery
The number of participants who require revision sinus surgery to address continuing sinus symptoms.
Time frame: 1-year post procedure
Population: All participants with 1 or more sinuses successfully treated with the XprESS device.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balloon Sinus Dilation | Revision Sinus Surgery | 1 Participants |