NCT02668302

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

The PIO II Study: A Randomized, Controlled, Blinded Trial to Evaluate the Safety and Efficacy of In-office Placement of a Steroid-eluting Sinus Implant Post-ethmoidectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Collin County Ear Nose & Throat · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Sinusitis, Ethmoidal

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Steroid-eluting sinus implant	PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released over 30 days
OTHER	Post-op standard of care	Post-op standard of care including debridement, irrigation, and/or topical steroids

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-01-29
• Last updated: 2018-10-12
• Results posted: 2018-10-12

Locations

1 site across 1 country: United States