| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable. | Posted | | Mean | Standard Deviation | mm^2 | | Day 45 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
| | Units | Counts |
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| Participants | | | sinus sides | |
| | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00016.54± 20.83
- OG00112.36± 16.10
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The null hypothesis was that there would no difference in FSO cross-sectional area between treatment and control sides at Day 45. | t-test, 2 sided | | 0.059 | Paired; the threshold for statistical significance was p = 0.05. | Mean Difference (Net) | 4.19 | Standard Deviation | 19.08 | 2-Sided | 95 | -0.2 | 8.6 | | | Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area | | Superiority | |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | mm^2 | | Baseline, Day 45, and Day 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | mm^3 | | Days 45 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | mm | | Days 45 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Days 45 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| Secondary | Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Need for post-operative intervention as determined by clinical investigators per endoscopy. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Count of Units | | sinus sides | | Days 21, 45, 90 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | | Posted | | Mean | Standard Deviation | mm^2 | | Day 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Days 45 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Days 45 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Days 21, 45, 90 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Days 21, 45, 90 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Days 21, 45, 90 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Day 21, 45, 90, and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Days 21, 45, 90 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Days 21, 45, 90 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable. | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants with data evaluable. | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
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| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable. | Posted | | Mean | Standard Deviation | mm^2 | | Day 45 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | mm^2 | | Baseline, Day 45, and Day 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | mm^3 | | Days 45 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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| 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. | Number of units (sinus sides) analyzed represents number of participants within the subgroup with data evaluable for the corresponding timepoint. | Posted | | Mean | Standard Deviation | mm | | Days 45 and 180 | sinus sides | sinus sides | | ID | Title | Description |
|---|
| OG000 | PROPEL Contour Sinus Implant | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. PROPEL Contour Sinus Implant: 370 mcg mometasone furoate-coated sinus implant | | OG001 | Balloon Sinus Dilation Alone | Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. Balloon Sinus Dilation Alone: No PROPEL Contour Sinus Implant |
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