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Completed

NCT Number: NCT02687438

The PIO (Propel In Office) III Study of 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

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Key information

Conditions

Chronic Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ENT and Allergy Associates, LLP, Lake Success, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Steroid-releasing sinus implant

Device

PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days

Other names: PROPEL

Post-op standard of care

Other

post-op standard of care including debridement, irrigation, and/or topical steroids

Other names: debridement, irrigation, topical steroids (e.g. mometasone furoate)

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

  3. Adhesion Scarring Score

    Time frame: Baseline, Day 14, Day 30, Day 90 and Month 6

    assessed by clinical investigators and by an independent reviewer

  4. 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

  5. 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

  6. Nasal Obstruction/ Congestion Score

    Time frame: Day 14, Day 30, Month 6

    scored by patients

  7. Sino-Nasal Outcome Test (SNOT 22)

    Time frame: Baseline, Day 14, Day 30, Day 90 and Month 6

    scored by patients

  8. Medication Requirements

    Time frame: Month 6 post-surgery versus Month 6 post-baseline

    evaluate the need for medication, assessed by clinical investigators

  9. Patient Preference Questionnaire

    Time frame: Baseline procedure, Day 90

    patient tolerability and satisfaction assessed by clinical investigators

  10. Implant Placement Success Rate

    Time frame: time of surgery

    successful access to, and placement of PROPEL Sinus Implant to the target site

Sponsors and collaborators

Lead sponsor

ENT and Allergy Associates, LLP

Other

Collaborators

  • Intersect ENT

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2016
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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