Chronic Sinusitis
Conditions
Brief summary
The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.
Detailed description
This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. The primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after FESS, and 2) balloon dilation is superior to FESS for a reduction in the number of postoperative debridements per patient. A minimum of 36 participants per arm is required to test the primary hypotheses. All participants will be followed through a minimum of 12 months post treatment.
Interventions
DEVICEBalloon Sinus Dilation
Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment
PROCEDUREFunctional Endoscopic Sinus Surgery
Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy
Sponsors
Entellus Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * maxillary sinus disease * chronic sinusitis
Exclusion criteria
* fungal disease * Samter's triad * hemophilia * prior sinus surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sinus Symptom Improvement | Baseline and 1-year | Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst). |
| Debridements | 1-year | Number of postoperative debridements per participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revision Rate | 1-year | Number of participants requiring repeat sinus procedures |
| Complication Rate | Duration of study (minimum of 12 months) | Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure |
| Recovery Time | 6-months | Mean time (days) after procedure for participants to return to normal activities |
Countries
United States
Participant flow
Recruitment details
Participants were screened, randomized, treated, and followed at 14 US centers from June 2011 to May 2014.
Pre-assignment details
After screening, informed consent, and baseline measures, participants were randomized 1:1 to balloon sinus dilation or FESS. The assigned procedure was to be performed within 60 days of randomization.
Participants by arm
| Arm | Count |
|---|---|
| Balloon Sinus Dilation Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment | 74 |
| Functional Endoscopic Sinus Surgery Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools. | 61 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Anatomic exclusion criteria identified | 0 | 3 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Unrelated medical issue (not treated) | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 9 |
Baseline characteristics
| Characteristic | Functional Endoscopic Sinus Surgery | Balloon Sinus Dilation | Total |
|---|---|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 14.1 | 46.1 years STANDARD_DEVIATION 13.6 | 46.9 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 68 Participants | 124 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 36 Participants | 48 Participants | 84 Participants |
| Gender Male | 25 Participants | 26 Participants | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 56 Participants | 65 Participants | 121 Participants |
| Region of Enrollment United States | 61 participants | 74 participants | 135 participants |
| Sino-Nasal Outcome Test (SNOT-20) overall score | 2.52 units on a scale STANDARD_DEVIATION 0.83 | 2.49 units on a scale STANDARD_DEVIATION 0.88 | 2.50 units on a scale STANDARD_DEVIATION 0.85 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 76 | 0 / 75 |
| serious Total, serious adverse events | 1 / 76 | 2 / 75 |
Outcome results
Primary
Debridements
Number of postoperative debridements per participant
Time frame: 1-year
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinus Dilation | Debridements | 0.23 debridements per participant | Standard Deviation 0.65 |
| Functional Endoscopic Sinus Surgery | Debridements | 1.03 debridements per participant | Standard Deviation 0.87 |
Comparison: Test for superiority of balloon dilation over FESS. Significance level=0.025 (1-sided alpha), power=90%, BD estimate=0.5, FESS estimate=1.5, SD for both arms=1.0. A total sample size of 46 participants (23 per arm) was required to test the hypothesis.p-value: <0.0001t-test, 1 sided
Primary
Sinus Symptom Improvement
Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).
Time frame: Baseline and 1-year
Population: All treated participants with matched pair SNOT-20 data at baseline and 1-year.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Sinus Symptom Improvement | Change from baseline | -1.59 units on a scale | Standard Deviation 1.08 |
| Balloon Sinus Dilation | Sinus Symptom Improvement | Mean overall SNOT-20 score at 1-year | 0.88 units on a scale | Standard Deviation 0.91 |
| Functional Endoscopic Sinus Surgery | Sinus Symptom Improvement | Change from baseline | -1.60 units on a scale | Standard Deviation 1 |
| Functional Endoscopic Sinus Surgery | Sinus Symptom Improvement | Mean overall SNOT-20 score at 1-year | 0.88 units on a scale | Standard Deviation 0.76 |
Comparison: Non-inferiority test to demonstrate that the long-term (1-year) change in sinus symptoms (overall SNOT-20 score) after balloon dilation is not worse than after FESS.p-value: <0.001t-test, 1 sided
Secondary
Complication Rate
Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure
Time frame: Duration of study (minimum of 12 months)
Population: All randomized participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balloon Sinus Dilation | Complication Rate | 0 Participants |
| Functional Endoscopic Sinus Surgery | Complication Rate | 0 Participants |
Secondary
Recovery Time
Mean time (days) after procedure for participants to return to normal activities
Time frame: 6-months
Population: All treated participants with 6-month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinus Dilation | Recovery Time | 1.7 days | Standard Deviation 1.3 |
| Functional Endoscopic Sinus Surgery | Recovery Time | 5.0 days | Standard Deviation 5.9 |
p-value: <0.0001t-test, 2 sided
Secondary
Revision Rate
Number of participants requiring repeat sinus procedures
Time frame: 1-year
Population: All treated participants with 1-year follow-up (or a revision surgery before 1-year follow-up if no 1-year follow-up).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balloon Sinus Dilation | Revision Rate | 1 Participants |
| Functional Endoscopic Sinus Surgery | Revision Rate | 1 Participants |
p-value: 0.628t-test, 2 sided