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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02687438
First Posted: February 22, 2016
Last Update Posted: November 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Intersect ENT
Information provided by (Responsible Party):
ENT and Allergy Associates, LLP
  Purpose
Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery

Condition Intervention
Chronic Sinusitis Device: Steroid-releasing sinus implant Other: Post-op standard of care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The PIO III Study: In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery

Resource links provided by NLM:


Further study details as provided by ENT and Allergy Associates, LLP:

Primary Outcome 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 Outcome 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


Enrollment: 20
Study Start Date: December 2015
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PROPEL
Other: Post-op standard of care
post-op standard of care including debridement, irrigation, and/or topical steroids
Other Name: debridement, irrigation, topical steroids (e.g. mometasone furoate)

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687438


Locations
United States, New York
ENT and Allergy Associates, LLP
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
Sponsors and Collaborators
ENT and Allergy Associates, LLP
Intersect ENT
Investigators
Principal Investigator: B.Todd Schaeffer, MD ENT and Allergy Associates, LLP
  More Information

Responsible Party: ENT and Allergy Associates, LLP
ClinicalTrials.gov Identifier: NCT02687438     History of Changes
Other Study ID Numbers: PIO III
First Submitted: January 26, 2016
First Posted: February 22, 2016
Last Update Posted: November 17, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ENT and Allergy Associates, LLP:
Steroid-eluting implant Mometasone Furoate

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents