An interventional study of Steroid-releasing sinus implant and Post-op standard of care in Chronic Sinusitis, sponsored by ENT and Allergy Associates, LLP. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-17.
Sponsored by ENT and Allergy Associates, LLP · Not applicable, Interventional, and Treatment
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.
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 313 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →This is the only study on the registry with ENT and Allergy Associates, LLP as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Post-op standard of care
PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days
Also known as: PROPEL
post-op standard of care including debridement, irrigation, and/or topical steroids
Also known as: debridement, irrigation, topical steroids (e.g. mometasone furoate)
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.