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

Overview

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

Full Title of Study: “The PIO III Study: In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2016

Detailed 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.

Interventions

  • Device: Steroid-releasing sinus implant
    • PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days
  • Other: Post-op standard of care
    • post-op standard of care including debridement, irrigation, and/or topical steroids

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • the change from baseline to day 90 in nasal obstruction / congestion score
    • Time Frame: baseline and 90 days from surgery
    • nasal obstruction/congestion scored by patients
  • the change from baseline to day 90 in bilateral polyp grade
    • Time Frame: baseline and 90 days from surgery
    • clinical investigator assessed and by an independent reviewer based on video-endoscopy review

Secondary Measures

  • Ethmoid Sinus Obstruction
    • Time Frame: Baseline, Day 14, Day 30, Day 90 and Month 6
    • 100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer
  • Bilateral Polyp Grading
    • Time Frame: Day 14, Day 30, Month 6
    • Bilateral polyp grade assessed by clinical investigator and by an independent reviewer based on video-endoscopy review
  • Adhesion Scarring Score
    • Time Frame: Baseline, Day 14, Day 30, Day 90 and Month 6
    • assessed by clinical investigators and by an independent reviewer
  • Inflammation Score
    • Time Frame: Baseline, Day 14, Day 30, Day 90 and Month 6
    • 100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer
  • Coagulum/ Crusting Score
    • Time Frame: Baseline, Day 14, Day 30, Day 90 and Month 6
    • 100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer
  • Nasal Obstruction/ Congestion Score
    • Time Frame: Day 14, Day 30, Month 6
    • scored by patients
  • Sino-Nasal Outcome Test (SNOT 22)
    • Time Frame: Baseline, Day 14, Day 30, Day 90 and Month 6
    • scored by patients
  • Medication Requirements
    • Time Frame: Month 6 post-surgery versus Month 6 post-baseline
    • evaluate the need for medication, assessed by clinical investigators
  • Patient Preference Questionnaire
    • Time Frame: Baseline procedure, Day 90
    • patient tolerability and satisfaction assessed by clinical investigators
  • Implant Placement Success Rate
    • Time Frame: time of surgery
    • successful access to, and placement of PROPEL Sinus Implant to the target site

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • ENT and Allergy Associates, LLP
  • Collaborator
    • Intersect ENT
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • B.Todd Schaeffer, MD, Principal Investigator, ENT and Allergy Associates, LLP

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