The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediat… (NCT02687438) | Clinical Trial Compass
CompletedNot Applicable
The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery
United States20 participantsStarted 2015-12
Plain-language summary
Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* 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:
* Not able to give consent
* Oral-steroid dependent condition
* Allergy or intolerance to corticosteroids
* Clinical evidence of bacterial sinusitis or invasive fungal sinusitis
* Pregnancy
What they're measuring
1
the change from baseline to day 90 in nasal obstruction / congestion score
Timeframe: baseline and 90 days from surgery
2
the change from baseline to day 90 in bilateral polyp grade