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

Phase 4

Completed

• Conditions: Chronic Sinusitis, Ethmoidal
• Interventions: Combination Product: Steroid-eluting sinus implant; Other: Post-op standard of care

• Registration Number: NCT02668302
• Lead Sponsor: Collin County Ear Nose & Throat

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-01-29
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2018-05-25
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-14
• Last Update Submitted: 2018-09-14
• Results First Posted: 2018-10-12
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Post-op standard of care	Bilateral in-office placement of a steroid-eluting sinus implant following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids
Treatment	Steroid-eluting sinus implant	Bilateral in-office placement of a steroid-eluting sinus implant following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids
Control	Post-op standard of care	Post-op standard of care, including debridement, irrigation, and topical steroids

Primary Outcome Measures

Name	Time	Method
Inflammation Score	Change from baseline to Day 90	Inflammation score was determined at baseline and Day 90 using a visual analogue scale (VAS), ranging from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes), as determined by an independent sinus surgeon based on a centralized, blinded video-endoscopy review.

Trial Locations

Locations (1)

Collin County Ear Nose & Throat; 🇺🇸 Frisco, Texas, United States