CompletedPhase 4

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

United States40 participantsStarted 2015-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Inflammation Score

Timeframe: Change from baseline to Day 90

Trial details

NCT IDNCT02668302

SponsorCollin County Ear Nose & Throat

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11

Results submitted2018-05-25

View on ClinicalTrials.gov More Chronic Sinusitis, Ethmoidal trials