At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 40 enrolled

Drug / intervention

Steroid-eluting sinus implant +1 morecombination

Likely dose

Steroid-eluting sinus implant 370μgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02668302

NCT02668302Phase 4Completed

Compare CT.gov

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

Collin County Ear Nose & Throat·interventional·Posted Jan 29, 2016·Updated Oct 12, 2018

In Brief

A Phase 4 clinical trial evaluating Steroid-eluting sinus implant and Post-op standard of care for Chronic Sinusitis, Ethmoidal. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChronic Sinusitis, Ethmoidal

CountriesUnited States

CollaboratorsIntersect ENT

Timeline

Phase 4CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartNov 2015

First PostedJan 2016

Primary CompletionNov 2016

TodayJul 2026

First PostedJan 29, 2016

Enrollment StartNov 1, 2015

Primary CompletionNov 1, 2016

TodayJul 2, 2026

Enrollment to primary: 1 yearPosted 10.4 years ago

Interventions

Steroid-eluting sinus implantcombination

PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released over 30 days

Post-op standard of careother

Post-op standard of care including debridement, irrigation, and/or topical steroids