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

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.

Timeline

Start

2015-11

Primary completion

2016-11

Completion

2016-11

Outcome

Missed primary endpoint

registry analysis (superiority test); Sinus Implant+Post-op Standard of Care vs Post-op Standard of Care; p = 0.4709; t-test, 2 sided NCT02668302 ↗

Drugs

Indications