Overview

This trial has been completed.

Condition chronic sinusitis
Treatments steroid-releasing sinus implant, post-op standard of care
Phase phase 4
Sponsor Collin County Ear Nose & Throat
Collaborator Intersect ENT
Start date November 2015
End date November 2016
Trial size 40 participants
Trial identifier NCT02668302, P2015-09

Summary

Randomized, controlled, double-blinded clinical trial with 40 patients randomized in 1:1 ratio to either treatment (bilateral in-office placement of Propel following ESS) or control (post ESS standard of care) group and followed for 6 months

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Steroid-releasing sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids)
steroid-releasing sinus implant PROPEL
PROPEL (Intersect ENT, Menlo Park, CA) containing 370μg of mometasone furoate designed for gradual release over 30 days
post-op standard of care debridement, irrigation, topical steroids (e.g., Nasonex)
post-op standard of care including debridement, irrigation, and/or topical steroids
(Active Comparator)
Post-op standard of care (i.e. debridement, irrigation, and topical steroids)
post-op standard of care debridement, irrigation, topical steroids (e.g., Nasonex)
post-op standard of care including debridement, irrigation, and/or topical steroids

Primary Outcomes

Measure
Inflammation score
time frame: Baseline, 3 months

Secondary Outcomes

Measure
Percent Ethmoid Sinus Obstruction
time frame: Baseline and Month 1, 3 & 6 by clinical investigators; Baseline and Month 1 & 3 by Independent Reviewer
Bilateral polyp grade
time frame: Baseline and Month 1, 3 & 6 by clinical investigators; Baseline and Month 1 & 3 by Independent Reviewer
Coagulum/crusting score
time frame: Baseline and Month 1, 3 & 6 by clinical investigators; Baseline and Month 1 & 3 by Independent Reviewer
Nasal Obstruction/Congestion score
time frame: Baseline, Month 1, 3 & 6
SNOT-22 score
time frame: Baseline, Month 1, 3 & 6
RSI score
time frame: Baseline, Month 1, 3 & 6
Need for post-op intervention
time frame: Month 3 & 6
Safety measures by recording all adverse events
time frame: Through 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Keith E Matheny, MD
Description This prospective, randomized, double-blinded, controlled trial aims to assess the efficacy of a drug-eluting sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids) compared to the same standard care alone (control). A total of 40 patients will be enrolled at one site and randomized in 1:1 ratio to either the treatment or control group. Patients will return for follow-up examination at 2 weeks and again at 1, 3 and 6 months after placement. Follow-up examination will consist of patient-reported outcomes and endoscopic grading by clinical investigators and an independent blinded reviewer based on video-endoscopy review.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Collin County Ear Nose & Throat.