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

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.

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