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

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

Detailed Description
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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.

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

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Device: Steroid-releasing sinus implant
* Other: Post-op standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days<br>* Other names: PROPEL;Other: Post-op standard of care<br>* post-op standard of care including debridement, irrigation, and/or topical steroids<br>* Other names: debridement, irrigation, topical steroids (e.g. mometasone furoate);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change from baseline to day 90 in nasal obstruction / congestion score | nasal obstruction/congestion scored by patients | baseline and 90 days from surgery | 
| the change from baseline to day 90 in bilateral polyp grade | 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 | 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 | 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 | assessed by clinical investigators and by an independent reviewer | Baseline, Day 14, Day 30, Day 90 and Month 6 | 
| Inflammation Score | 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 | 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 | scored by patients | Day 14, Day 30, Month 6 | 
| Sino-Nasal Outcome Test (SNOT 22) | scored by patients | Baseline, Day 14, Day 30, Day 90 and Month 6 | 
| Medication Requirements | evaluate the need for medication, assessed by clinical investigators | Month 6 post-surgery versus Month 6 post-baseline | 
| Patient Preference Questionnaire | patient tolerability and satisfaction assessed by clinical investigators | Baseline procedure, Day 90 | 
| Implant Placement Success Rate | successful access to, and placement of PROPEL Sinus Implant to the target site | time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Steroid-eluting implant Mometasone Furoate