Back to resultsThe PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant
Primary Purpose
Chronic Sinusitis, Ethmoidal
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Steroid-eluting sinus implant
Post-op standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sinusitis, Ethmoidal focused on measuring Steroid-eluting sinus implant, Mometasone furoate, Endoscopic sinus surgery
Eligibility Criteria
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
Sites / Locations
- Collin County Ear Nose & Throat
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control
Arm Description
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
Post-op standard of care, including debridement, irrigation, and topical steroids
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02668302
First Posted
January 4, 2016
Last Updated
September 14, 2018
Sponsor
Collin County Ear Nose & Throat
Collaborators
Intersect ENT
1. Study Identification
Unique Protocol Identification Number
NCT02668302
Brief Title
The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Collin County Ear Nose & Throat
Collaborators
Intersect ENT
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis, Ethmoidal
Keywords
Steroid-eluting sinus implant, Mometasone furoate, Endoscopic sinus surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Post-op standard of care, including debridement, irrigation, and topical steroids
Intervention Type
Combination Product
Intervention Name(s)
Steroid-eluting sinus implant
Other Intervention Name(s)
PROPEL
Intervention Description
PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released over 30 days
Intervention Type
Other
Intervention Name(s)
Post-op standard of care
Other Intervention Name(s)
Debridement, irrigation, topical steroids
Intervention Description
Post-op standard of care including debridement, irrigation, and/or topical steroids
Primary Outcome Measure Information:
Title
Inflammation Score
Description
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.
Time Frame
Change from baseline to Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith E Matheny, MD
Organizational Affiliation
Collin County Ear Nose & Throat
Official's Role
Principal Investigator
Facility Information:
Facility Name
Collin County Ear Nose & Throat
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant
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