Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
ENT and Allergy Associates, LLP
Lake Success, New York, United States
ENT and Allergy Associates, LLP
New York, New York, United States
ENT and Allergy Associates, LLP
Port Jefferson, New York, United States
ENT and Allergy Associates, LLP
White Plains, New York, United States
the change from baseline to day 90 in nasal obstruction / congestion score
nasal obstruction/congestion scored by patients
Time frame: 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
Time frame: baseline and 90 days from surgery
Ethmoid Sinus Obstruction
100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer
Time frame: 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
Time frame: Day 14, Day 30, Month 6
Adhesion Scarring Score
assessed by clinical investigators and by an independent reviewer
Time frame: 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
Time frame: 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
Time frame: Baseline, Day 14, Day 30, Day 90 and Month 6
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Nasal Obstruction/ Congestion Score
scored by patients
Time frame: Day 14, Day 30, Month 6
Sino-Nasal Outcome Test (SNOT 22)
scored by patients
Time frame: Baseline, Day 14, Day 30, Day 90 and Month 6
Medication Requirements
evaluate the need for medication, assessed by clinical investigators
Time frame: Month 6 post-surgery versus Month 6 post-baseline
Patient Preference Questionnaire
patient tolerability and satisfaction assessed by clinical investigators
Time frame: Baseline procedure, Day 90
Implant Placement Success Rate
successful access to, and placement of PROPEL Sinus Implant to the target site
Time frame: time of surgery