A Clinical Evaluation of PROPEL® Contour Sinus Implant

Study Overview
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Brief Summary
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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
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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.

Official Title
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The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation

Conditions
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Chronic Rhinosinusitis (Diagnosis)

Intervention / Treatment
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* Device: PROPEL Contour Sinus Implant
* Procedure: Balloon Sinus Dilation Alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 years of age or older. Patient is willing and able to comply with protocol requirements. Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and Rhinology, Rhinosinusitis 2021 (ICAR:RS) guidelines. 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. 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: Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs prior to implant placement. Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade > 2) unless reduced 30 days prior to the baseline procedure Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions. Known history of allergy or intolerance to corticosteroids or mometasone furoate. Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers. 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. Patients with monopolar pacemakers (older designs, with lower resistance to interference) or ICD's (implantable cardioverter defibrillator). Patients with implantable, body worn devices such as insulin pumps. Evidence of purulence coming from paranasal sinuses or ostiomeatal complex. Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue). Active viral illness (e.g., flu, shingles). Use of parenteral or injected steroids (e.g. Kenalog) 30 days prior to the baseline procedure. Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROPEL Contour Sinus Implant<br>Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. | Device: PROPEL Contour Sinus Implant<br>* 370 mcg mometasone furoate-coated sinus implant<br>|
| Active Comparator: Balloon Sinus Dilation Alone<br>Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. | Procedure: Balloon Sinus Dilation Alone<br>* No PROPEL Contour Sinus Implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 45 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Day 45, and Day 180 | 
| 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. | Days 45 and 180 | 
| 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. | Days 45 and 180 | 
| 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. | Days 45 and 180 | 
| Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators | Need for post-operative intervention as determined by clinical investigators per endoscopy. | Days 21, 45, 90 and 180 | 
| 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. | Day 180 | 
| 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. | Days 45 and 180 | 
| 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. | Days 45 and 180 | 
| 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. | Days 21, 45, 90 and 180 | 
| 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. | Days 21, 45, 90 and 180 | 
| 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. | Days 21, 45, 90 and 180 | 
| 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. | Day 21, 45, 90, and 180 | 
| 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. | Days 21, 45, 90 and 180 | 
| 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. | Days 21, 45, 90 and 180 | 
| 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. | Day 180 | 
| 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. | Day 180 | 
| 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frontal Sinus, Balloon Dilation