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

Collin County Ear Nose & Throat

Status and phase: Completed; Phase 4

Conditions: Chronic Sinusitis, Ethmoidal

Treatments: Other: Post-op standard of care; Combination Product: Steroid-eluting sinus implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02668302

P2015-09

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Treatment

Experimental group

Description:

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

Treatment:

Combination Product: Steroid-eluting sinus implant

Other: Post-op standard of care

Control

Active Comparator group

Description:

Post-op standard of care, including debridement, irrigation, and topical steroids

Treatment:

Other: Post-op standard of care