The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery
NCT ID: NCT02687438
Last Updated: 2016-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2015-12-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
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 (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days
Post-op standard of care
post-op standard of care including debridement, irrigation, and/or topical steroids
Interventions
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Steroid-releasing sinus implant
PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days
Post-op standard of care
post-op standard of care including debridement, irrigation, and/or topical steroids
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of CRS (Chronic Rhinosinusitis) based on the 2015 Clinical Practice Guideline for Adult Sinusitis \[6\]
* Prior ESS (Ethmoid Sinus Surgery) including bilateral total ethmoidectomy at least 90 days prior to being considered for this study
* Planned ESS includes bilateral polypectomy
* ESS including bilateral polypectomy has been successfully completed without significant complication that, in the opinion of the investigator, would confound study results, and the patient's anatomy remains amenable to implant placement.
* Bilateral polyposis (minimum grade 2 on each side) originating from the ethmoid sinus region
* Complaints of at least 2 of the 5 hallmark symptoms of chronic sinusitis: nasal obstruction/congestion, post-nasal discharge, thick nasal discharge, facial pain/pressure, or decreased sense of smell.
* Minimum symptom threshold (Nasal Obstruction/Congestion minimum score of 2 on scale from 0 to 3)
* Failed medical therapy within the preceding 12 months
Exclusion Criteria
* Oral-steroid dependent condition
* Allergy or intolerance to corticosteroids
* Clinical evidence of bacterial sinusitis or invasive fungal sinusitis
* Pregnancy
18 Years
ALL
Yes
Sponsors
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Intersect ENT
INDUSTRY
ENT and Allergy Associates, LLP
OTHER
Responsible Party
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Principal Investigators
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B.Todd Schaeffer, MD
Role: PRINCIPAL_INVESTIGATOR
ENT and Allergy Associates, LLP
Locations
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ENT and Allergy Associates, LLP
Lake Success, New York, United States
ENT and Allergy Associates, LLP
New York, New York, United States
ENT and Allergy Associates, LLP
Port Jefferson, New York, United States
ENT and Allergy Associates, LLP
White Plains, New York, United States
Countries
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Other Identifiers
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PIO III
Identifier Type: -
Identifier Source: org_study_id