In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia

Study Overview
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Brief Summary
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A randomized controlled trial

Detailed Description
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This is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the United States. Study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.

Official Title
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A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation

Conditions
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Chronic Sinusitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patient has provided written informed consent using a form approved by the reviewing IRB. Patient is 18 years of age or older. Patient is willing and able to comply with protocol requirements. Patient has CRS defined as sinonasal inflammation persisting for more than 12 weeks and complains of at least 2 of the 4 following symptoms: nasal blockage/obstruction/congestion, nasal blockage/obstruction/congestion, nasal discharge (anterior/posterior), facial pain/pressure, reduction/loss of smell CRS diagnosis confirmed by CT scan within 3 months prior to enrollment Bilateral frontal sinusitis confirmed by Lund-Mackay score of ≥1 on each side Post-endoscopic sinus surgery, patient has bilateral obstruction of the frontal sinus ostia by scarring and/or polypoid edema. Patient is a candidate for an in-office balloon dilation procedure. In the opinion of the investigator, treatment with the Propel Mini Sinus Implant as an adjunct to balloon sinus dilation is technically feasible and clinically indicated in the frontal sinus ostia. Exclusion Criteria: Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus of grade 3 or 4 unless reduced prior to randomization in the study. 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. Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis. Active viral illness (e.g., flu, shingles). Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments through Day 180 post-procedure. Currently participating in another clinical trial.

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROPEL Mini Sinus Implant<br>Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation | Device: PROPEL Mini Sinus Implant<br>* Sinus implant with 370 mcg of mometasone furoate released over 30 days<br>* Other names: PROPEL Mini;Procedure: Balloon Sinus Dilation Alone<br> <br> |
| Active Comparator: Balloon Sinus Dilation Alone<br>In-office balloon dilation of the contralateral frontal sinus ostia (FSO) without implant placement | Procedure: Balloon Sinus Dilation Alone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency Rate | Patency of the frontal recess/frontal sinus ostia (FSO) was evaluated on a 3-point grading scale from 0 to 2, with 0=Patent, 1=Restenosed/partially occluded, and 2=Occluded. The percentage of sinuses with patency grade 0 and 1 was used to calculate the patency rate. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation Score | Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes) | Day 30 | 

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