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

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Steroid-releasing sinus implant
Post-op standard of care
Sponsored by
ENT and Allergy Associates, LLP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring Steroid-eluting implant Mometasone Furoate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ENT and Allergy Associates, LLP
  • ENT and Allergy Associates, LLP
  • ENT and Allergy Associates, LLP
  • ENT and Allergy Associates, LLP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Steroid-releasing sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids)

Outcomes

Primary Outcome Measures

the change from baseline to day 90 in nasal obstruction / congestion score
nasal obstruction/congestion scored by patients
the change from baseline to day 90 in bilateral polyp grade
clinical investigator assessed and by an independent reviewer based on video-endoscopy review

Secondary Outcome Measures

Ethmoid Sinus Obstruction
100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer
Bilateral Polyp Grading
Bilateral polyp grade assessed by clinical investigator and by an independent reviewer based on video-endoscopy review
Adhesion Scarring Score
assessed by clinical investigators and by an independent reviewer
Inflammation Score
100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer
Coagulum/ Crusting Score
100mm Visual Analogue Scale (VAS) assessed by clinical investigators and by an independent reviewer
Nasal Obstruction/ Congestion Score
scored by patients
Sino-Nasal Outcome Test (SNOT 22)
scored by patients
Medication Requirements
evaluate the need for medication, assessed by clinical investigators
Patient Preference Questionnaire
patient tolerability and satisfaction assessed by clinical investigators
Implant Placement Success Rate
successful access to, and placement of PROPEL Sinus Implant to the target site

Full Information

First Posted
January 26, 2016
Last Updated
November 16, 2016
Sponsor
ENT and Allergy Associates, LLP
Collaborators
Intersect ENT
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1. Study Identification

Unique Protocol Identification Number
NCT02687438
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ENT and Allergy Associates, LLP
Collaborators
Intersect ENT

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
Steroid-eluting implant Mometasone Furoate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Steroid-releasing sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids)
Intervention Type
Device
Intervention Name(s)
Steroid-releasing sinus implant
Other Intervention Name(s)
PROPEL
Intervention Description
PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days
Intervention Type
Other
Intervention Name(s)
Post-op standard of care
Other Intervention Name(s)
debridement, irrigation, topical steroids (e.g. mometasone furoate)
Intervention Description
post-op standard of care including debridement, irrigation, and/or topical steroids
Primary Outcome Measure Information:
Title
the change from baseline to day 90 in nasal obstruction / congestion score
Description
nasal obstruction/congestion scored by patients
Time Frame
baseline and 90 days from surgery
Title
the change from baseline to day 90 in bilateral polyp grade
Description
clinical investigator assessed and by an independent reviewer based on video-endoscopy review
Time Frame
baseline and 90 days from surgery
Secondary Outcome Measure Information:
Title
Ethmoid Sinus Obstruction
Description
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
Title
Bilateral Polyp Grading
Description
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
Title
Adhesion Scarring Score
Description
assessed by clinical investigators and by an independent reviewer
Time Frame
Baseline, Day 14, Day 30, Day 90 and Month 6
Title
Inflammation Score
Description
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
Title
Coagulum/ Crusting Score
Description
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
Title
Nasal Obstruction/ Congestion Score
Description
scored by patients
Time Frame
Day 14, Day 30, Month 6
Title
Sino-Nasal Outcome Test (SNOT 22)
Description
scored by patients
Time Frame
Baseline, Day 14, Day 30, Day 90 and Month 6
Title
Medication Requirements
Description
evaluate the need for medication, assessed by clinical investigators
Time Frame
Month 6 post-surgery versus Month 6 post-baseline
Title
Patient Preference Questionnaire
Description
patient tolerability and satisfaction assessed by clinical investigators
Time Frame
Baseline procedure, Day 90
Title
Implant Placement Success Rate
Description
successful access to, and placement of PROPEL Sinus Implant to the target site
Time Frame
time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B.Todd Schaeffer, MD
Organizational Affiliation
ENT and Allergy Associates, LLP
Official's Role
Principal Investigator
Facility Information:
Facility Name
ENT and Allergy Associates, LLP
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
ENT and Allergy Associates, LLP
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
ENT and Allergy Associates, LLP
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
ENT and Allergy Associates, LLP
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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