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

Chronic Sinusitis, Ethmoidal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668302
• Other study ID #: P2015-09
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: September 2018
• Source: Collin County Ear Nose & Throat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Sinusitis, Ethmoidal
• Ethmoid Sinusitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
United States	Collin County Ear Nose & Throat	Frisco	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Collin County Ear Nose & Throat	Intersect ENT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation Score	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.	Change from baseline to Day 90