Phase 4
N=40
The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant
Chronic Sinusitis, Ethmoidal
Bottom Line
View on ClinicalTrials.gov: NCT02668302 ↗Enrolled (actual)
40
Serious AEs
7.5%
Results posted
Oct 2018
Primary outcome: Primary: Inflammation Score — 26.7; 26.8; 21.5; 17.6 units on a scale — p=0.4709
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Steroid-eluting sinus implant (Combination_product); Post-op standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Collin County Ear Nose & Throat
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inflammation Score |
26.7; 26.8; 21.5; 17.6; -5.2; -9.7 | 0.4709 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02668302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.