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

Chronic Sinusitis, Ethmoidal Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Chronic Sinusitis, Ethmoidal
• Ethmoid Sinusitis
• Sinusitis

• NCT number: NCT02668302
• Study type: Interventional
• Source: Collin County Ear Nose & Throat
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Completion date: November 2016