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

Completed · Phase 4

Conditions studied: Chronic Sinusitis, Ethmoidal

In brief

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.

Key facts

Study ID

NCT02668302

Run by

Collin County Ear Nose & Throat

People needed

40

Starts

2015-11-01

Expected to finish

2016-11-01

Last updated by the study team

2018-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known history of intolerance to corticosteroids or an oral steroid-dependent condition.
• Known history of immune deficiency, insulin-dependent diabetes, cataracts, or glaucoma

Where it is running

• Collin County Ear Nose & Throat — Frisco, Texas, United States

Full record on ClinicalTrials.gov

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