The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery

Completed · Not applicable

Conditions studied: Chronic Sinusitis

In brief

Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery

Key facts

Study ID

NCT02687438

Run by

ENT and Allergy Associates, LLP

People needed

20

Starts

2015-12-01

Expected to finish

2016-02-01

Last updated by the study team

2016-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Not able to give consent
• Oral-steroid dependent condition
• Allergy or intolerance to corticosteroids
• Clinical evidence of bacterial sinusitis or invasive fungal sinusitis
• Pregnancy

Where it is running

• 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

Full record on ClinicalTrials.gov

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