In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia (FRONTIER)

A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation

A randomized controlled trial

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Device: PROPEL Mini Sinus Implant; Procedure: Balloon Sinus Dilation Alone

Detailed Description

This is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the United States. Study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Sacramento ENT
  • Florida
    • Boca Raton, Florida, United States, 33487
      • ENT Assoicates of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • ENT of Georgia
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Advanced ENT and Allergy
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Associated Surgical Specialists
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's ENT Specialists
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • BreatheAmerica of Albuquerque
  • New York
    • New York, New York, United States, 10016
      • Madison ENT
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Ohio Sinus Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Patient has provided written informed consent using a form approved by the reviewing IRB.
• Patient is 18 years of age or older.
• Patient is willing and able to comply with protocol requirements.
• Patient has CRS defined as sinonasal inflammation persisting for more than 12 weeks and complains of at least 2 of the 4 following symptoms: nasal blockage/obstruction/congestion, nasal blockage/obstruction/congestion, nasal discharge (anterior/posterior), facial pain/pressure, reduction/loss of smell
• CRS diagnosis confirmed by CT scan within 3 months prior to enrollment
• Bilateral frontal sinusitis confirmed by Lund-Mackay score of ≥1 on each side
• Post-endoscopic sinus surgery, patient has bilateral obstruction of the frontal sinus ostia by scarring and/or polypoid edema.
• Patient is a candidate for an in-office balloon dilation procedure.
• In the opinion of the investigator, treatment with the Propel Mini Sinus Implant as an adjunct to balloon sinus dilation is technically feasible and clinically indicated in the frontal sinus ostia.

Exclusion Criteria:

• Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus of grade 3 or 4 unless reduced prior to randomization in the study.
• Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
• Known history of allergy or intolerance to corticosteroids or mometasone furoate.
• Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis.
• Active viral illness (e.g., flu, shingles).
• Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments through Day 180 post-procedure.
• Currently participating in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROPEL Mini Sinus Implant; Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation	Device: PROPEL Mini Sinus Implant; Sinus implant with 370 mcg of mometasone furoate released over 30 days; Other Names: PROPEL Mini; Procedure: Balloon Sinus Dilation Alone
Active Comparator: Balloon Sinus Dilation Alone; In-office balloon dilation of the contralateral frontal sinus ostia (FSO) without implant placement	Procedure: Balloon Sinus Dilation Alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency Rate	Patency of the frontal recess/frontal sinus ostia (FSO) was evaluated on a 3-point grading scale from 0 to 2, with 0=Patent, 1=Restenosed/partially occluded, and 2=Occluded. The percentage of sinuses with patency grade 0 and 1 was used to calculate the patency rate.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation Score	Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)	Day 30

Collaborators and Investigators

• Sponsor: Intersect ENT
• Investigators: Principal Investigator: Stacey Silvers, Madison ENT

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Frontal Sinus; Balloon Dilation
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: P500-0616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No