Clinical trial NCT02687438: The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery
Official title: The PIO III Study: In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Keywords: Steroid-eluting implant Mometasone Furoate
Lead sponsor: ENT and Allergy Associates, LLP
Sponsor class: OTHER
Collaborators: name: Intersect ENT
First posted: 2016-02-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the change from baseline to day 90 in nasal obstruction / congestion score
timeFrame: baseline and 90 days from surgery
measure: the change from baseline to day 90 in bilateral polyp grade
timeFrame: baseline and 90 days from surgery
Secondary outcomes:
measure: Ethmoid Sinus Obstruction
timeFrame: Baseline, Day 14, Day 30, Day 90 and Month 6
measure: Bilateral Polyp Grading
timeFrame: Day 14, Day 30, Month 6
measure: Adhesion Scarring Score
timeFrame: Baseline, Day 14, Day 30, Day 90 and Month 6
measure: Inflammation Score
timeFrame: Baseline, Day 14, Day 30, Day 90 and Month 6
measure: Coagulum/ Crusting Score
timeFrame: Baseline, Day 14, Day 30, Day 90 and Month 6
measure: Nasal Obstruction/ Congestion Score
timeFrame: Day 14, Day 30, Month 6
measure: Sino-Nasal Outcome Test (SNOT 22)
timeFrame: Baseline, Day 14, Day 30, Day 90 and Month 6
measure: Medication Requirements
timeFrame: Month 6 post-surgery versus Month 6 post-baseline
measure: Patient Preference Questionnaire
timeFrame: Baseline procedure, Day 90
measure: Implant Placement Success Rate
timeFrame: time of surgery
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
city: New York
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
city: Port Jefferson
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
city: White Plains
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
Study officials:
affiliation: ENT and Allergy Associates, LLP
name: B.Todd Schaeffer, MD
role: PRINCIPAL_INVESTIGATOR
References: