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

November 16, 2016 updated by: ENT and Allergy Associates, LLP

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Lake Success, New York, United States, 11042
        • ENT and Allergy Associates, LLP
      • New York, New York, United States, 10016
        • ENT and Allergy Associates, LLP
      • Port Jefferson, New York, United States, 11777
        • ENT and Allergy Associates, LLP
      • White Plains, New York, United States, 10601
        • ENT and Allergy Associates, LLP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Steroid-releasing sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids)
Device: Steroid-releasing sinus implant
PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days
Other Names:
  • PROPEL
Other: Post-op standard of care
post-op standard of care including debridement, irrigation, and/or topical steroids
Other Names:
  • debridement, irrigation, topical steroids (e.g. mometasone furoate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 90 days from surgery
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
baseline and 90 days from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Day 14, Day 30, Day 90 and Month 6
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
Day 14, Day 30, Month 6
Adhesion Scarring Score
Time Frame: Baseline, Day 14, Day 30, Day 90 and Month 6
assessed by clinical investigators and by an independent reviewer
Baseline, Day 14, Day 30, Day 90 and Month 6
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
Baseline, Day 14, Day 30, Day 90 and Month 6
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
Baseline, Day 14, Day 30, Day 90 and Month 6
Nasal Obstruction/ Congestion Score
Time Frame: Day 14, Day 30, Month 6
scored by patients
Day 14, Day 30, Month 6
Sino-Nasal Outcome Test (SNOT 22)
Time Frame: Baseline, Day 14, Day 30, Day 90 and Month 6
scored by patients
Baseline, Day 14, Day 30, Day 90 and Month 6
Medication Requirements
Time Frame: Month 6 post-surgery versus Month 6 post-baseline
evaluate the need for medication, assessed by clinical investigators
Month 6 post-surgery versus Month 6 post-baseline
Patient Preference Questionnaire
Time Frame: Baseline procedure, Day 90
patient tolerability and satisfaction assessed by clinical investigators
Baseline procedure, Day 90
Implant Placement Success Rate
Time Frame: time of surgery
successful access to, and placement of PROPEL Sinus Implant to the target site
time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ENT and Allergy Associates, LLP

Collaborators

Intersect ENT

Investigators

  • Principal Investigator: B.Todd Schaeffer, MD, ENT and Allergy Associates, LLP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIO III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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