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

E

ENT and Allergy Associates, LLP

Status

Completed

Conditions

Chronic Sinusitis

Treatments

Device: Steroid-releasing sinus implant
Other: Post-op standard of care

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02687438
PIO III

Details and patient eligibility

About

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

Full description

The PROPEL mometasone furoate-releasing implant (Intersect ENT, Menlo Park, CA) is the first FDA-approved device for reducing the need for post-operative interventions by maintaining patency and delivering steroid medication directly into the ethmoid cavity following surgery. Five recently published clinical trials have demonstrated that the mometasone furoate-releasing implant placed in the hospital operating room or in the office setting produces statistically significant reductions in inflammation, polyp formation, and postoperative adhesions. In addition, the implant has been found to significantly reduce the need for postoperative prescription of oral steroids and to decrease the frequency of postoperative lysis of adhesions. Minimal adverse effects were reported in these trials.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Treatment
Experimental group
Description:
Steroid-releasing sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids)
Treatment:
Other: Post-op standard of care
Device: Steroid-releasing sinus implant

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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