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| Name | Class |
|---|---|
| Intersect ENT | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Steroid-releasing sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid-releasing sinus implant | Device | PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| B.Todd Schaeffer, MD | ENT and Allergy Associates, LLP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT and Allergy Associates, LLP | Lake Success | New York | 11042 | United States | ||
| ENT and Allergy Associates, LLP |
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|
| Post-op standard of care | Other | post-op standard of care including debridement, irrigation, and/or topical steroids |
|
|
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 |
| New York |
| New York |
| 10016 |
| United States |
| ENT and Allergy Associates, LLP | Port Jefferson | New York | 11777 | United States |
| ENT and Allergy Associates, LLP | White Plains | New York | 10601 | United States |
| ID | Term |
|---|---|
| D003646 | Debridement |
| D007507 | Therapeutic Irrigation |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D008919 | Investigative Techniques |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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