The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery

Not Applicable

Completed

• Conditions: Chronic Sinusitis

• Registration Number: NCT02687438
• Lead Sponsor: ENT and Allergy Associates, LLP

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-26
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-22
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
the change from baseline to day 90 in nasal obstruction / congestion score	baseline and 90 days from surgery	nasal obstruction/congestion scored by patients

Secondary Outcome Measures

Name	Time	Method
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
Nasal Obstruction/ Congestion Score	Day 14, Day 30, Month 6	scored by patients
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
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
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
Implant Placement Success Rate	time of surgery	successful access to, and placement of PROPEL Sinus Implant to the target site
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
Sino-Nasal Outcome Test (SNOT 22)	Baseline, Day 14, Day 30, Day 90 and Month 6	scored by patients

Trial Locations

Locations (1)

ENT and Allergy Associates, LLP; 🇺🇸 White Plains, New York, United States