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

Chronic Sinusitis Clinical Trial

Official title:

The PIO III Study: In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687438
• Other study ID #: PIO III
• Status: Completed
• Phase: N/A
• First received: January 26, 2016
• Last updated: November 16, 2016
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2016
• Source: ENT and Allergy Associates, LLP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• Steroid-releasing sinus implant
PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days

Other:
• Post-op standard of care
post-op standard of care including debridement, irrigation, and/or topical steroids

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
ENT and Allergy Associates, LLP	Intersect ENT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change from baseline to day 90 in nasal obstruction / congestion score	nasal obstruction/congestion scored by patients	baseline and 90 days from surgery	No
Primary	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	No
Secondary	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	No
Secondary	Bilateral Polyp Grading	Bilateral polyp grade assessed by clinical investigator and by an independent reviewer based on video-endoscopy review	Day 14, Day 30, Month 6	No
Secondary	Adhesion Scarring Score	assessed by clinical investigators and by an independent reviewer	Baseline, Day 14, Day 30, Day 90 and Month 6	No
Secondary	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	No
Secondary	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	No
Secondary	Nasal Obstruction/ Congestion Score	scored by patients	Day 14, Day 30, Month 6	No
Secondary	Sino-Nasal Outcome Test (SNOT 22)	scored by patients	Baseline, Day 14, Day 30, Day 90 and Month 6	No
Secondary	Medication Requirements	evaluate the need for medication, assessed by clinical investigators	Month 6 post-surgery versus Month 6 post-baseline	No
Secondary	Patient Preference Questionnaire	patient tolerability and satisfaction assessed by clinical investigators	Baseline procedure, Day 90	No
Secondary	Implant Placement Success Rate	successful access to, and placement of PROPEL Sinus Implant to the target site	time of surgery	No