Chronic Sinusitis
Conditions
Keywords
Steroid-eluting implant Mometasone Furoate
Brief summary
Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery
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
DEVICESteroid-releasing sinus implant
PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days
post-op standard of care including debridement, irrigation, and/or topical steroids
Sponsors
Intersect ENT
ENT and Allergy Associates, LLP
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change from baseline to day 90 in nasal obstruction / congestion score | baseline and 90 days from surgery | nasal obstruction/congestion scored by patients |
| the change from baseline to day 90 in bilateral polyp grade | baseline and 90 days from surgery | clinical investigator assessed and by an independent reviewer based on video-endoscopy review |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adhesion Scarring Score | Baseline, Day 14, Day 30, Day 90 and Month 6 | assessed by clinical investigators and by an independent reviewer |
| Inflammation Score | 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 | 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 | Day 14, Day 30, Month 6 | scored by patients |
| Ethmoid Sinus Obstruction | Baseline, Day 14, Day 30, Day 90 and Month 6 | 100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer |
| Medication Requirements | Month 6 post-surgery versus Month 6 post-baseline | evaluate the need for medication, assessed by clinical investigators |
| Patient Preference Questionnaire | Baseline procedure, Day 90 | patient tolerability and satisfaction assessed by clinical investigators |
| Implant Placement Success Rate | time of surgery | successful access to, and placement of PROPEL Sinus Implant to the target site |
| Sino-Nasal Outcome Test (SNOT 22) | Baseline, Day 14, Day 30, Day 90 and Month 6 | scored by patients |
| Bilateral Polyp Grading | Day 14, Day 30, Month 6 | Bilateral polyp grade assessed by clinical investigator and by an independent reviewer based on video-endoscopy review |
Countries
United States
Outcome results
None listed