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

NCT02668302 | Completed Phase 4 Results

• 1 other identifier: P2015-09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Steroid-eluting sinus implant; Mometasone furoate; Endoscopic sinus surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment

EXPERIMENTAL

Bilateral in-office placement of a steroid-eluting sinus implant following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids

Combination Product: Steroid-eluting sinus implant; Other: Post-op standard of care

Control

ACTIVE COMPARATOR

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

Other: Post-op standard of care

Interventions

Steroid-eluting sinus implant COMBINATION_PRODUCT

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

Also known as: PROPEL

Treatment

Post-op standard of care OTHER

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

Also known as: Debridement, irrigation, topical steroids

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known history of intolerance to corticosteroids or an oral steroid-dependent condition.
• Known history of immune deficiency, insulin-dependent diabetes, cataracts, or glaucoma

Sponsors & Collaborators

• Collin County Ear Nose & Throat: lead
• Intersect ENT: collaborator

Study Sites (1)

Collin County Ear Nose & Throat

Frisco, Texas, 75034, United States

Location

MeSH Terms

Interventions

Mometasone Furoate; Debridement; Therapeutic Irrigation; Steroids

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Surgical Procedures, Operative; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Limitations and Caveats

* Small sample size * Large intragroup variability * Technical issues with video-endoscopies resulted in missing values for the primary endpoint in 7 (35%) treatment and 2 (10%) control participants, not allowing to draw any conclusions

Results Point of Contact

• Title: Keith E Matheny, MD (Principal Investigator)
• Organization: Collin County ENT

kmatheny618@gmail.com

(972) 596-4005

Study Officials

• Keith E Matheny, MD

  Collin County Ear Nose & Throat

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients were wearing eye masked and noise-cancelling headsets during placement and follow-up endoscopies. The primary outcome was assessed by an independent sinus surgeon based on a centralized, blinded video-endoscopy review.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients assigned to the treatment group underwent a bilateral in-office placement of a steroid-eluting sinus implant 7 days following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids. Patients randomized to the control group received same standard of care alone.

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 29, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 12, 2018
• Results First Posted: October 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)