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

NCT02668302 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-10-12

Study results available
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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.

Conditions

  • Chronic Sinusitis, Ethmoidal

Interventions

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

Sponsors & Collaborators

  • Intersect ENT

    collaborator INDUSTRY

  • Collin County Ear Nose & Throat

    lead OTHER

Principal Investigators

  • Keith E Matheny, MD · Collin County Ear Nose & Throat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02668302 on ClinicalTrials.gov