Chronic Rhinosinusitis (Diagnosis)
Conditions
Keywords
Frontal Sinus, Balloon Dilation
Brief summary
The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)
Detailed description
A post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 study centers. After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure™ Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the control.
Interventions
DEVICEPROPEL Contour Sinus Implant
370 mcg mometasone furoate-coated sinus implant
PROCEDUREBalloon Sinus Dilation Alone
No PROPEL Contour Sinus Implant
Sponsors
Intersect ENT
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Intrapatient control in which eligible subjects will receive the PROPEL Contour Sinus Implant (Treatment) on one side, and no implant (Control) on the contralateral side.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patient is 18 years of age or older. 2. Patient is willing and able to comply with protocol requirements. 3. Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and Rhinology, Rhinosinusitis 2021 (ICAR:RS) guidelines. 4. Bilateral disease in the frontal sinuses (Lund-Mackay CT score of ≥1 on each side) on CT scan within 90 days prior to the baseline. 5. A successfully completed in-office bilateral balloon dilation of the FSO with no complication on either side that, in the opinion of the clinical investigator is amenable for PROPEL Contour Sinus Implant placement in both FSO
Exclusion criteria
1. Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs prior to implant placement. 2. Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade \> 2) unless reduced 30 days prior to the baseline procedure 3. Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions. 4. Known history of allergy or intolerance to corticosteroids or mometasone furoate. 5. Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers. 6. Patients with electronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators (e.g. deep brain stimulation), programmable cerebrospinal fluid (CSF) shunts. 7. Patients with monopolar pacemakers (older designs, with lower resistance to interference) or ICD's (implantable cardioverter defibrillator). 8. Patients with implantable, body worn devices such as insulin pumps. 9. Evidence of purulence coming from paranasal sinuses or ostiomeatal complex. 10. Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue). 11. Active viral illness (e.g., flu, shingles). 12. Use of parenteral or injected steroids (e.g. Kenalog) 30 days prior to the baseline procedure. 13. Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in FSO Patency by Blinded Reviewer | Day 45 | Side-to-side difference in frontal sinus ostium (FSO) patency at Day 45 based on cross-sectional area of FSO by computed tomography (CT) measurements performed by an independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer | Days 45 and 180 | FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, is assessed by blinded reviewer. FSOT volume was measured via computer-assisted segmentation of CT images. |
| CT FSO Minimum Diameter by Blinded Reviewer | Days 45 and 180 | CT FSO minimum diameter assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. FSO minimum diameter was measured via computer-assisted segmentation of CT images. |
| CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer | Days 45 and 180 | CT Zinreich's modified Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. Zinreich's modified Lund-Mackay scale ranges from 0 to 5. Higher scores indicate a worse outcome. |
| Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Days 21, 45, 90 and 180 | Need for post-operative intervention as determined by clinical investigators per endoscopy. |
| CT Cross-sectional Area of FSO by Blinded Reviewer | Day 180 | CT cross-sectional area of FSO assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images. |
| CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer | Days 45 and 180 | CT Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome. |
| CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators | Days 45 and 180 | CT Lund-Mackay for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome. |
| Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators | Days 21, 45, 90 and 180 | Endoscopic grading of adhesion/scarring grade in the frontal recess/FSO by clinical investigators. The adhesion/scarring grade in the frontal recess/FSO scale ranges from 0 to 4. Higher scores indicate a worse outcome. |
| FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer | Baseline, Day 45, and Day 180 | FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer. FSO cross-sectional area was measured via computer-assisted segmentation of CT images. |
| Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators | Days 21, 45, 90 and 180 | Endoscopic grading of polypoid edema in the frontal recess/FSO by clinical investigators. Polypoid edema in the frontal recess/FSO scale ranges from 0 to 3. Higher scores indicate a worse outcome. |
| Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators | Day 21, 45, 90, and 180 | Endoscopic grading of adhesion/scarring grade in the ethmoid sinus by clinical investigators. The adhesion/scarring grade in the ethmoid sinus scale ranges from 0 to 4. Higher scores indicate a worse outcome. |
| Polyp Grade in the Ethmoid Sinus by Clinical Investigators | Days 21, 45, 90 and 180 | Endoscopic grading of polyp grade in the ethmoid sinus by clinical investigators. Polyp grade in the ethmoid sinus scale ranges from 0 to 3. Higher scores indicate a worse outcome. |
| CRS Side-specific Symptom Score by Subject | Days 21, 45, 90 and 180 | Subject-reported outcome of chronic rhinosinusitis (CRS) side-specific symptom score. The chronic rhinosinusitis side-specific symptom score scale ranges from 0 to 30. Higher scores indicate a worse outcome. |
| SNOT-22 Score by Subject | Day 180 | Subject-reported outcome of SNOT-22 score. The Sino-Nasal Outcome Test, 22 item (SNOT-22) is a validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a 6-point scale, ranging from a score of 0 (no problem) to 5 (problem as bad as it can be). The maximum total score for all symptoms is equal to 110. Higher scores indicate a worse outcome. |
| RSI Score by Subject | Day 180 | Subject-reported outcome of RSI score. The Rhinosinusitis Symptom Inventory (RSI) scale ranges from 0 to 60. Higher scores indicate a worse outcome. |
| Implant Delivery Success by Clinical Investigators | Baseline | Number of subjects who underwent successful access and deployment of the PROPEL Contour Sinus Implant into the FSO. Delivery is considered successful if the procedure concludes with correct implant placement on the intended side, even if a second attempt to place the implant is necessary. An attempted deployment occurs when the investigator introduces the delivery system into the subject's nostril with the intent of placing an implant. |
| Inflammation Score in the Frontal Recess/FSO by Clinical Investigators | Days 21, 45, 90 and 180 | Endoscopic grading of inflammation score in the frontal recess/FSO by clinical investigators. Inflammation score in the frontal recess/FSO ranges from 0 to 100. Higher scores indicate a worse outcome. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from fourteen locations in the United States.
Pre-assignment details
A total of 89 patients were assessed for eligibility. Eight patients did not meet inclusion criteria or met exclusion criteria. One patient withdrew from the study prior to randomization. A total of 80 patients met final eligibility and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the frontal sinus ostium occurred on the randomized side. The opposing side served as control.
PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 13.38 |
| Allergic rhinitis diagnosed by physician Yes, any severity | 68 participants |
| Allergic rhinitis diagnosed by physician Yes, mild | 39 participants |
| Allergic rhinitis diagnosed by physician Yes, moderate | 27 participants |
| Allergic rhinitis diagnosed by physician Yes, severe | 2 participants |
| Aspirin intolerance or allergy | 2 participants |
| Asthma diagnosed by physician Yes, any severity | 15 participants |
| Asthma diagnosed by physician Yes, mild | 13 participants |
| Asthma diagnosed by physician Yes, moderate | 2 participants |
| Asthma diagnosed by physician Yes, severe | 0 participants |
| Lund-Mackay score Frontal sinus score (left + right) | 2.19 units on a scale STANDARD_DEVIATION 0.48 |
| Lund-Mackay score Total score (left + right) | 9.21 units on a scale STANDARD_DEVIATION 3.83 |
| Number of prior endoscopic sinus surgeries (ESS) 0 | 36 participants |
| Number of prior endoscopic sinus surgeries (ESS) 1 | 26 participants |
| Number of prior endoscopic sinus surgeries (ESS) 2 | 12 participants |
| Number of prior endoscopic sinus surgeries (ESS) 3 | 4 participants |
| Number of prior endoscopic sinus surgeries (ESS) ≥ 4 | 2 participants |
| Race/Ethnicity, Customized Asian | 7 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants |
| Race/Ethnicity, Customized Other | 2 participants |
| Race/Ethnicity, Customized White | 69 participants |
| Region of Enrollment United States | 80 participants |
| Sex/Gender, Customized Female | 30 participants |
| Sex/Gender, Customized Male | 50 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 15 / 80 | 16 / 80 |
| serious Total, serious adverse events | 1 / 80 | 1 / 80 |
Outcome results
Primary
Difference in FSO Patency by Blinded Reviewer
Side-to-side difference in frontal sinus ostium (FSO) patency at Day 45 based on cross-sectional area of FSO by computed tomography (CT) measurements performed by an independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.
Time frame: Day 45
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROPEL Contour Sinus Implant | Difference in FSO Patency by Blinded Reviewer | 16.54 mm^2 | Standard Deviation 20.83 |
| Balloon Sinus Dilation Alone | Difference in FSO Patency by Blinded Reviewer | 12.36 mm^2 | Standard Deviation 16.1 |
Comparison: The null hypothesis was that there would no difference in FSO cross-sectional area between treatment and control sides at Day 45.p-value: 0.05995% CI: [-0.2, 8.6]t-test, 2 sided
Secondary
Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators
Endoscopic grading of adhesion/scarring grade in the ethmoid sinus by clinical investigators. The adhesion/scarring grade in the ethmoid sinus scale ranges from 0 to 4. Higher scores indicate a worse outcome.
Time frame: Day 21, 45, 90, and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators | Day 21 | 0.28 score on a scale | Standard Deviation 0.67 |
| PROPEL Contour Sinus Implant | Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators | Day 45 | 0.34 score on a scale | Standard Deviation 0.72 |
| PROPEL Contour Sinus Implant | Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators | Day 90 | 0.26 score on a scale | Standard Deviation 0.66 |
| PROPEL Contour Sinus Implant | Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators | Day 180 | 0.29 score on a scale | Standard Deviation 0.78 |
| Balloon Sinus Dilation Alone | Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators | Day 180 | 0.39 score on a scale | Standard Deviation 0.75 |
| Balloon Sinus Dilation Alone | Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators | Day 21 | 0.30 score on a scale | Standard Deviation 0.71 |
| Balloon Sinus Dilation Alone | Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators | Day 90 | 0.39 score on a scale | Standard Deviation 0.74 |
| Balloon Sinus Dilation Alone | Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators | Day 45 | 0.35 score on a scale | Standard Deviation 0.73 |
Comparison: Day 21p-value: 0.8395% CI: [-0.2, 0.2]t-test, 2 sided
Comparison: Day 45p-value: 0.82995% CI: [-0.2, 0.1]t-test, 2 sided
Comparison: Day 90p-value: 0.13295% CI: [-0.3, 0]t-test, 2 sided
Comparison: Day 180p-value: 0.3195% CI: [-0.3, 0.1]t-test, 2 sided
Secondary
Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators
Endoscopic grading of adhesion/scarring grade in the frontal recess/FSO by clinical investigators. The adhesion/scarring grade in the frontal recess/FSO scale ranges from 0 to 4. Higher scores indicate a worse outcome.
Time frame: Days 21, 45, 90 and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators | Day 21 | 0.37 score on a scale | Standard Deviation 0.63 |
| PROPEL Contour Sinus Implant | Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators | Day 45 | 0.30 score on a scale | Standard Deviation 0.62 |
| PROPEL Contour Sinus Implant | Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators | Day 90 | 0.21 score on a scale | Standard Deviation 0.54 |
| PROPEL Contour Sinus Implant | Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators | Day 180 | 0.24 score on a scale | Standard Deviation 0.56 |
| Balloon Sinus Dilation Alone | Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators | Day 180 | 0.45 score on a scale | Standard Deviation 0.74 |
| Balloon Sinus Dilation Alone | Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators | Day 21 | 0.41 score on a scale | Standard Deviation 0.61 |
| Balloon Sinus Dilation Alone | Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators | Day 90 | 0.48 score on a scale | Standard Deviation 0.78 |
| Balloon Sinus Dilation Alone | Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators | Day 45 | 0.48 score on a scale | Standard Deviation 0.75 |
Comparison: Day 21p-value: 0.53795% CI: [-0.2, 0.1]t-test, 2 sided
Comparison: Day 45p-value: 0.0195% CI: [-0.3, 0]t-test, 2 sided
Comparison: Day 90p-value: 0.00395% CI: [-0.4, -0.1]t-test, 2 sided
Comparison: Day 180p-value: 0.00795% CI: [-0.4, -0.1]t-test, 2 sided
Secondary
CRS Side-specific Symptom Score by Subject
Subject-reported outcome of chronic rhinosinusitis (CRS) side-specific symptom score. The chronic rhinosinusitis side-specific symptom score scale ranges from 0 to 30. Higher scores indicate a worse outcome.
Time frame: Days 21, 45, 90 and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | CRS Side-specific Symptom Score by Subject | Day 21 | 6.19 score on a scale | Standard Deviation 4.74 |
| PROPEL Contour Sinus Implant | CRS Side-specific Symptom Score by Subject | Day 45 | 4.75 score on a scale | Standard Deviation 3.77 |
| PROPEL Contour Sinus Implant | CRS Side-specific Symptom Score by Subject | Day 90 | 4.42 score on a scale | Standard Deviation 4.21 |
| PROPEL Contour Sinus Implant | CRS Side-specific Symptom Score by Subject | Day 180 | 3.86 score on a scale | Standard Deviation 4.32 |
| Balloon Sinus Dilation Alone | CRS Side-specific Symptom Score by Subject | Day 180 | 4.22 score on a scale | Standard Deviation 4.76 |
| Balloon Sinus Dilation Alone | CRS Side-specific Symptom Score by Subject | Day 21 | 6.25 score on a scale | Standard Deviation 4.95 |
| Balloon Sinus Dilation Alone | CRS Side-specific Symptom Score by Subject | Day 90 | 4.42 score on a scale | Standard Deviation 4.46 |
| Balloon Sinus Dilation Alone | CRS Side-specific Symptom Score by Subject | Day 45 | 4.68 score on a scale | Standard Deviation 3.9 |
Comparison: Day 21p-value: 0.86895% CI: [-0.7, 0.6]t-test, 2 sided
Comparison: Day 45p-value: 0.82395% CI: [-0.5, 0.7]t-test, 2 sided
Comparison: Day 90p-value: 195% CI: [-0.5, 0.5]t-test, 2 sided
Comparison: Day 180p-value: 0.18895% CI: [-0.8, 0.2]t-test, 2 sided
Secondary
CT Cross-sectional Area of FSO by Blinded Reviewer
CT cross-sectional area of FSO assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.
Time frame: Day 180
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROPEL Contour Sinus Implant | CT Cross-sectional Area of FSO by Blinded Reviewer | 17.72 mm^2 | Standard Deviation 21.05 |
| Balloon Sinus Dilation Alone | CT Cross-sectional Area of FSO by Blinded Reviewer | 17.81 mm^2 | Standard Deviation 19.96 |
Comparison: Day 180p-value: 0.97195% CI: [-4.9, 4.8]t-test, 2 sided
Secondary
CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer
FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, is assessed by blinded reviewer. FSOT volume was measured via computer-assisted segmentation of CT images.
Time frame: Days 45 and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer | Day 45 | 383.11 mm^3 | Standard Deviation 437.19 |
| PROPEL Contour Sinus Implant | CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer | Day 180 | 386.86 mm^3 | Standard Deviation 413.56 |
| Balloon Sinus Dilation Alone | CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer | Day 45 | 332.17 mm^3 | Standard Deviation 399.68 |
| Balloon Sinus Dilation Alone | CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer | Day 180 | 414.30 mm^3 | Standard Deviation 427.56 |
Comparison: Day 45p-value: 0.30695% CI: [-47.5, 149.4]t-test, 2 sided
Comparison: Day 180p-value: 0.56795% CI: [-122.5, 67.6]t-test, 2 sided
Secondary
CT FSO Minimum Diameter by Blinded Reviewer
CT FSO minimum diameter assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. FSO minimum diameter was measured via computer-assisted segmentation of CT images.
Time frame: Days 45 and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | CT FSO Minimum Diameter by Blinded Reviewer | Day 45 | 2.38 mm | Standard Deviation 1.94 |
| PROPEL Contour Sinus Implant | CT FSO Minimum Diameter by Blinded Reviewer | Day 180 | 2.56 mm | Standard Deviation 2.23 |
| Balloon Sinus Dilation Alone | CT FSO Minimum Diameter by Blinded Reviewer | Day 45 | 1.89 mm | Standard Deviation 1.79 |
| Balloon Sinus Dilation Alone | CT FSO Minimum Diameter by Blinded Reviewer | Day 180 | 2.54 mm | Standard Deviation 2.13 |
Comparison: Day 45p-value: 0.03195% CI: [0, 0.9]t-test, 2 sided
Comparison: Day 180p-value: 0.94395% CI: [-0.5, 0.5]t-test, 2 sided
Secondary
CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
CT Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.
Time frame: Days 45 and 180
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer | Day 45 | 0.77 score on a scale | Standard Deviation 0.48 |
| PROPEL Contour Sinus Implant | CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer | Day 180 | 0.72 score on a scale | Standard Deviation 0.56 |
| Balloon Sinus Dilation Alone | CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer | Day 45 | 0.77 score on a scale | Standard Deviation 0.56 |
| Balloon Sinus Dilation Alone | CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer | Day 180 | 0.67 score on a scale | Standard Deviation 0.55 |
Comparison: Day 45p-value: 195% CI: [-0.1, 0.1]t-test, 2 sided
Comparison: Day 180p-value: 0.28895% CI: [0, 0.1]t-test, 2 sided
Secondary
CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators
CT Lund-Mackay for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.
Time frame: Days 45 and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators | Day 45 | 0.59 score on a scale | Standard Deviation 0.59 |
| PROPEL Contour Sinus Implant | CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators | Day 180 | 0.53 score on a scale | Standard Deviation 0.64 |
| Balloon Sinus Dilation Alone | CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators | Day 45 | 0.68 score on a scale | Standard Deviation 0.59 |
| Balloon Sinus Dilation Alone | CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators | Day 180 | 0.59 score on a scale | Standard Deviation 0.63 |
Comparison: Day 45p-value: 0.22595% CI: [-0.2, 0.1]t-test, 2 sided
Comparison: Day 180p-value: 0.38895% CI: [-0.2, 0.1]t-test, 2 sided
Secondary
CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
CT Zinreich's modified Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. Zinreich's modified Lund-Mackay scale ranges from 0 to 5. Higher scores indicate a worse outcome.
Time frame: Days 45 and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer | Day 45 | 1.23 score on a scale | Standard Deviation 1.22 |
| PROPEL Contour Sinus Implant | CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer | Day 180 | 1.22 score on a scale | Standard Deviation 1.4 |
| Balloon Sinus Dilation Alone | CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer | Day 45 | 1.28 score on a scale | Standard Deviation 1.38 |
| Balloon Sinus Dilation Alone | CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer | Day 180 | 1.05 score on a scale | Standard Deviation 1.27 |
Comparison: Day 45p-value: 0.71595% CI: [-0.3, 0.2]t-test, 2 sided
Comparison: Day 180p-value: 0.12995% CI: [0, 0.4]t-test, 2 sided
Secondary
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer
FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer. FSO cross-sectional area was measured via computer-assisted segmentation of CT images.
Time frame: Baseline, Day 45, and Day 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer | Change from baseline to Day 45 | 2.63 mm^2 | Standard Deviation 9.95 |
| PROPEL Contour Sinus Implant | FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer | Change from baseline to Day 180 | 3.20 mm^2 | Standard Deviation 10.97 |
| Balloon Sinus Dilation Alone | FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer | Change from baseline to Day 45 | 1.15 mm^2 | Standard Deviation 11.09 |
| Balloon Sinus Dilation Alone | FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer | Change from baseline to Day 180 | 5.95 mm^2 | Standard Deviation 13.78 |
Comparison: Day 45p-value: 0.32895% CI: [-1.5, 4.5]t-test, 2 sided
Comparison: Day 180p-value: 0.06395% CI: [-5.7, 0.2]t-test, 2 sided
Secondary
Implant Delivery Success by Clinical Investigators
Number of subjects who underwent successful access and deployment of the PROPEL Contour Sinus Implant into the FSO. Delivery is considered successful if the procedure concludes with correct implant placement on the intended side, even if a second attempt to place the implant is necessary. An attempted deployment occurs when the investigator introduces the delivery system into the subject's nostril with the intent of placing an implant.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PROPEL Contour Sinus Implant | Implant Delivery Success by Clinical Investigators | 80 Participants |
Secondary
Inflammation Score in the Frontal Recess/FSO by Clinical Investigators
Endoscopic grading of inflammation score in the frontal recess/FSO by clinical investigators. Inflammation score in the frontal recess/FSO ranges from 0 to 100. Higher scores indicate a worse outcome.
Time frame: Days 21, 45, 90 and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | Inflammation Score in the Frontal Recess/FSO by Clinical Investigators | Day 21 | 25.94 score on a scale | Standard Deviation 29.31 |
| PROPEL Contour Sinus Implant | Inflammation Score in the Frontal Recess/FSO by Clinical Investigators | Day 45 | 19.17 score on a scale | Standard Deviation 27.68 |
| PROPEL Contour Sinus Implant | Inflammation Score in the Frontal Recess/FSO by Clinical Investigators | Day 90 | 21.97 score on a scale | Standard Deviation 34.1 |
| PROPEL Contour Sinus Implant | Inflammation Score in the Frontal Recess/FSO by Clinical Investigators | Day 180 | 17.30 score on a scale | Standard Deviation 31.45 |
| Balloon Sinus Dilation Alone | Inflammation Score in the Frontal Recess/FSO by Clinical Investigators | Day 180 | 24.46 score on a scale | Standard Deviation 33.45 |
| Balloon Sinus Dilation Alone | Inflammation Score in the Frontal Recess/FSO by Clinical Investigators | Day 21 | 28.85 score on a scale | Standard Deviation 30.86 |
| Balloon Sinus Dilation Alone | Inflammation Score in the Frontal Recess/FSO by Clinical Investigators | Day 90 | 28.62 score on a scale | Standard Deviation 33.8 |
| Balloon Sinus Dilation Alone | Inflammation Score in the Frontal Recess/FSO by Clinical Investigators | Day 45 | 26.67 score on a scale | Standard Deviation 32.16 |
Comparison: Day 21p-value: 0.63495% CI: [-12.8, 7.9]t-test, 2 sided
Comparison: Day 45p-value: 0.04895% CI: [-15.2, -0.1]t-test, 2 sided
Comparison: Day 90p-value: 0.02895% CI: [-14.7, -0.9]t-test, 2 sided
Comparison: Day 180p-value: 0.04195% CI: [-13.2, -0.3]t-test, 2 sided
Secondary
Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators
Need for post-operative intervention as determined by clinical investigators per endoscopy.
Time frame: Days 21, 45, 90 and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| PROPEL Contour Sinus Implant | Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Day 21 | 5 sinus sides |
| PROPEL Contour Sinus Implant | Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Day 45 | 14 sinus sides |
| PROPEL Contour Sinus Implant | Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Day 90 | 12 sinus sides |
| PROPEL Contour Sinus Implant | Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Day 180 | 12 sinus sides |
| Balloon Sinus Dilation Alone | Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Day 180 | 16 sinus sides |
| Balloon Sinus Dilation Alone | Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Day 21 | 5 sinus sides |
| Balloon Sinus Dilation Alone | Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Day 90 | 16 sinus sides |
| Balloon Sinus Dilation Alone | Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Day 45 | 17 sinus sides |
Comparison: Day 21p-value: 195% CI: [0.28, 3.6]t-test, 2 sided
Comparison: Day 45p-value: 0.45395% CI: [0.36, 1.73]t-test, 2 sided
Comparison: Day 90p-value: 0.21995% CI: [0.31, 1.61]t-test, 2 sided
Comparison: Day 180p-value: 0.28995% CI: [0.31, 1.61]t-test, 2 sided
Secondary
Polyp Grade in the Ethmoid Sinus by Clinical Investigators
Endoscopic grading of polyp grade in the ethmoid sinus by clinical investigators. Polyp grade in the ethmoid sinus scale ranges from 0 to 3. Higher scores indicate a worse outcome.
Time frame: Days 21, 45, 90 and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | Polyp Grade in the Ethmoid Sinus by Clinical Investigators | Day 21 | 0.29 score on a scale | Standard Deviation 0.65 |
| PROPEL Contour Sinus Implant | Polyp Grade in the Ethmoid Sinus by Clinical Investigators | Day 45 | 0.30 score on a scale | Standard Deviation 0.61 |
| PROPEL Contour Sinus Implant | Polyp Grade in the Ethmoid Sinus by Clinical Investigators | Day 90 | 0.31 score on a scale | Standard Deviation 0.72 |
| PROPEL Contour Sinus Implant | Polyp Grade in the Ethmoid Sinus by Clinical Investigators | Day 180 | 0.29 score on a scale | Standard Deviation 0.64 |
| Balloon Sinus Dilation Alone | Polyp Grade in the Ethmoid Sinus by Clinical Investigators | Day 180 | 0.31 score on a scale | Standard Deviation 0.64 |
| Balloon Sinus Dilation Alone | Polyp Grade in the Ethmoid Sinus by Clinical Investigators | Day 21 | 0.32 score on a scale | Standard Deviation 0.62 |
| Balloon Sinus Dilation Alone | Polyp Grade in the Ethmoid Sinus by Clinical Investigators | Day 90 | 0.39 score on a scale | Standard Deviation 0.73 |
| Balloon Sinus Dilation Alone | Polyp Grade in the Ethmoid Sinus by Clinical Investigators | Day 45 | 0.34 score on a scale | Standard Deviation 0.66 |
Comparison: Day 21p-value: 0.66695% CI: [-0.2, 0.1]t-test, 2 sided
Comparison: Day 45p-value: 0.49795% CI: [-0.2, 0.1]t-test, 2 sided
Comparison: Day 90p-value: 0.23595% CI: [-0.2, 0]t-test, 2 sided
Comparison: Day 180p-value: 0.67795% CI: [-0.1, 0.1]t-test, 2 sided
Secondary
Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators
Endoscopic grading of polypoid edema in the frontal recess/FSO by clinical investigators. Polypoid edema in the frontal recess/FSO scale ranges from 0 to 3. Higher scores indicate a worse outcome.
Time frame: Days 21, 45, 90 and 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators | Day 21 | 0.63 score on a scale | Standard Deviation 0.82 |
| PROPEL Contour Sinus Implant | Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators | Day 45 | 0.53 score on a scale | Standard Deviation 0.87 |
| PROPEL Contour Sinus Implant | Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators | Day 90 | 0.53 score on a scale | Standard Deviation 0.93 |
| PROPEL Contour Sinus Implant | Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators | Day 180 | 0.52 score on a scale | Standard Deviation 0.85 |
| Balloon Sinus Dilation Alone | Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators | Day 180 | 0.71 score on a scale | Standard Deviation 0.93 |
| Balloon Sinus Dilation Alone | Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators | Day 21 | 0.88 score on a scale | Standard Deviation 1.04 |
| Balloon Sinus Dilation Alone | Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators | Day 90 | 0.80 score on a scale | Standard Deviation 1.02 |
| Balloon Sinus Dilation Alone | Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators | Day 45 | 0.77 score on a scale | Standard Deviation 1.01 |
Comparison: Day 21p-value: 0.06395% CI: [-0.5, 0]t-test, 2 sided
Comparison: Day 45p-value: 0.01595% CI: [-0.4, -0.1]t-test, 2 sided
Comparison: Day 90p-value: 0.00795% CI: [-0.4, -0.1]t-test, 2 sided
Comparison: Day 180p-value: 0.03495% CI: [-0.4, 0]t-test, 2 sided
Secondary
RSI Score by Subject
Subject-reported outcome of RSI score. The Rhinosinusitis Symptom Inventory (RSI) scale ranges from 0 to 60. Higher scores indicate a worse outcome.
Time frame: Day 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROPEL Contour Sinus Implant | RSI Score by Subject | 7.7 score on a scale | Standard Deviation 7.84 |
| Balloon Sinus Dilation Alone | RSI Score by Subject | 7.7 score on a scale | Standard Deviation 7.84 |
Secondary
SNOT-22 Score by Subject
Subject-reported outcome of SNOT-22 score. The Sino-Nasal Outcome Test, 22 item (SNOT-22) is a validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a 6-point scale, ranging from a score of 0 (no problem) to 5 (problem as bad as it can be). The maximum total score for all symptoms is equal to 110. Higher scores indicate a worse outcome.
Time frame: Day 180
Population: Number of units (sinus sides) analyzed represents number of participants with data evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROPEL Contour Sinus Implant | SNOT-22 Score by Subject | 17.84 score on a scale | Standard Deviation 17.62 |
| Balloon Sinus Dilation Alone | SNOT-22 Score by Subject | 17.84 score on a scale | Standard Deviation 17.62 |
Post Hoc
CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup
FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer. FSOT volume was measured via computer-assisted segmentation of CT images.
Time frame: Days 45 and 180
Population: Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Day 45 | 306.06 mm^3 | Standard Deviation 389.9 |
| PROPEL Contour Sinus Implant | CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Day 180 | 282.89 mm^3 | Standard Deviation 394.99 |
| Balloon Sinus Dilation Alone | CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Day 45 | 244.52 mm^3 | Standard Deviation 394.58 |
| Balloon Sinus Dilation Alone | CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Day 180 | 334.86 mm^3 | Standard Deviation 451.2 |
Comparison: Day 45p-value: 0.37595% CI: [-76.7, 199.8]t-test, 2 sided
Comparison: Day 180p-value: 0.43295% CI: [-184.1, 80.2]t-test, 2 sided
Post Hoc
CT FSO Minimum Diameter by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup
CT FSO minimum diameter as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer. FSO minimum diameter was measured via computer-assisted segmentation of CT images.
Time frame: Days 45 and 180
Population: Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | CT FSO Minimum Diameter by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Day 45 | 2.31 mm | Standard Deviation 2.04 |
| PROPEL Contour Sinus Implant | CT FSO Minimum Diameter by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Day 180 | 2.18 mm | Standard Deviation 2.07 |
| Balloon Sinus Dilation Alone | CT FSO Minimum Diameter by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Day 45 | 1.57 mm | Standard Deviation 1.6 |
| Balloon Sinus Dilation Alone | CT FSO Minimum Diameter by Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Day 180 | 2.33 mm | Standard Deviation 2.23 |
Comparison: Day 45p-value: 0.02395% CI: [0.1, 1.4]t-test, 2 sided
Comparison: Day 180p-value: 0.64695% CI: [-0.8, 0.5]t-test, 2 sided
Post Hoc
Difference in FSO Patency at Day 45 - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup
Side-to-side difference in FSO patency at Day 45 based on cross-sectional area of FSO by CT measurements performed by an independent, blinded reviewer, as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer.
Time frame: Day 45
Population: Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROPEL Contour Sinus Implant | Difference in FSO Patency at Day 45 - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | 14.98 mm^2 | Standard Deviation 18.21 |
| Balloon Sinus Dilation Alone | Difference in FSO Patency at Day 45 - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | 8.70 mm^2 | Standard Deviation 12.88 |
p-value: 0.02595% CI: [0.8, 11.7]t-test, 2 sided
Post Hoc
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup
FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer, as assessed within the subgroup of participants with a baseline Zinreich's modified Lund-Mackay score ≥ 1 on both sides per independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.
Time frame: Baseline, Day 45, and Day 180
Population: Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROPEL Contour Sinus Implant | FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Change from baseline to Day 45 | 4.87 mm^2 | Standard Deviation 9.59 |
| PROPEL Contour Sinus Implant | FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Change from baseline to Day 180 | 4.29 mm^2 | Standard Deviation 12.46 |
| Balloon Sinus Dilation Alone | FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Change from baseline to Day 45 | 0.89 mm^2 | Standard Deviation 10.87 |
| Balloon Sinus Dilation Alone | FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer - Baseline Zinreich's Modified Lund-Mackay Score ≥ 1 on Both Sides by Independent Reviewer Subgroup | Change from baseline to Day 180 | 7.74 mm^2 | Standard Deviation 16.12 |
Comparison: Day 45p-value: 0.0495% CI: [0.2, 7.8]t-test, 2 sided
Comparison: Day 180p-value: 0.0995% CI: [-7.5, 0.6]t-test, 2 sided