The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant

Study Overview
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Brief Summary
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Randomized, controlled, blinded clinical trial with 40 patients randomized in a 1:1 ratio to either treatment (bilateral in-office placement of a drug-eluting implant in the ethmoid sinuses following ethmoidectomy) or control (post-op standard of care) group and followed for 6 months.

Detailed Description
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This prospective, randomized, controlled, blinded trial aimed to assess the efficacy of a drug-eluting sinus implant placed following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids, compared to the same standard of care alone (control). Patients returned for follow-up examination at 2 weeks and again at 1, 3 and 6 months after placement. Follow-up examination consisted of patient-reported outcomes and endoscopic grading by clinical investigators and an independent sinus surgeon based on a centralized, blinded video-endoscopy review.

Official Title
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The PIO II Study: A Randomized, Controlled, Blinded Trial to Evaluate the Safety and Efficacy of In-office Placement of a Steroid-eluting Sinus Implant Post-ethmoidectomy

Conditions
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Chronic Sinusitis, Ethmoidal

Intervention / Treatment
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* Combination Product: Steroid-eluting sinus implant
* Other: Post-op standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of chronic rhinosinusitis, defined by the AAO-HNS 2015 guidelines, including presence of bilateral ethmoid disease. ESS including bilateral ethmoidectomy with middle meatal antrostomy within 7 days prior to scheduled implant placement. Concurrent septoplasty and surgical treatment of the other paranasal sinuses also permitted. Exclusion Criteria: Known history of intolerance to corticosteroids or an oral steroid-dependent condition. Known history of immune deficiency, insulin-dependent diabetes, cataracts, or glaucoma

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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No

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: Patients assigned to the treatment group underwent a bilateral in-office placement of a steroid-eluting sinus implant 7 days following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids. Patients randomized to the control group received same standard of care alone.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Bilateral in-office placement of a steroid-eluting sinus implant following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids | Combination Product: Steroid-eluting sinus implant<br>* PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released over 30 days<br>* Other names: PROPEL;Other: Post-op standard of care<br>* Post-op standard of care including debridement, irrigation, and/or topical steroids<br>* Other names: Debridement, irrigation, topical steroids;|
| Active Comparator: Control<br>Post-op standard of care, including debridement, irrigation, and topical steroids | Other: Post-op standard of care<br>* Post-op standard of care including debridement, irrigation, and/or topical steroids<br>* Other names: Debridement, irrigation, topical steroids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation Score | Inflammation score was determined at baseline and Day 90 using a visual analogue scale (VAS), ranging from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes), as determined by an independent sinus surgeon based on a centralized, blinded video-endoscopy review. | Change from baseline to Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Steroid-eluting sinus implant, Mometasone furoate, Endoscopic sinus surgery