- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02668302
The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant
September 14, 2018 updated by: Collin County Ear Nose & Throat
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Frisco, Texas, United States, 75034
- Collin County Ear Nose & Throat
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
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
|
PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released over 30 days
Other Names:
Post-op standard of care including debridement, irrigation, and/or topical steroids
Other Names:
|
Active Comparator: Control
Post-op standard of care, including debridement, irrigation, and topical steroids
|
Post-op standard of care including debridement, irrigation, and/or topical steroids
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammation Score
Time Frame: Change from baseline to Day 90
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Keith E Matheny, MD, Collin County Ear Nose & Throat
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
January 4, 2016
First Submitted That Met QC Criteria
January 28, 2016
First Posted (Estimate)
January 29, 2016
Study Record Updates
Last Update Posted (Actual)
October 12, 2018
Last Update Submitted That Met QC Criteria
September 14, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2015-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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