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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02880514
Recruitment Status : Completed
First Posted : August 26, 2016
Results First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Intersect ENT

Tracking Information
First Submitted Date  ICMJE August 18, 2016
First Posted Date  ICMJE August 26, 2016
Results First Submitted Date  ICMJE June 6, 2018
Results First Posted Date  ICMJE December 10, 2018
Last Update Posted Date December 10, 2018
Study Start Date  ICMJE August 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
Patency Rate [ Time Frame: Day 30 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
Inflammation Score [ Time Frame: Day 30 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
Inflammation Score [ Time Frame: Day 30 ]
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
  • Inflammation Score [ Time Frame: Day 90 ]
  • Inflammation Score [ Time Frame: Day 180 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia
Official Title  ICMJE A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation
Brief Summary A randomized controlled trial
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Sinusitis
Intervention  ICMJE
  • Device: PROPEL Mini Sinus Implant
    Sinus implant with 370 mcg of mometasone furoate released over 30 days
    Other Name: PROPEL Mini
  • Procedure: Balloon Sinus Dilation Alone
Study Arms  ICMJE
  • 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
    Interventions:
    • Device: PROPEL Mini Sinus Implant
    • 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
    Intervention: Procedure: Balloon Sinus Dilation Alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2016)
100
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02880514
Other Study ID Numbers  ICMJE P500-0616
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Intersect ENT
Study Sponsor  ICMJE Intersect ENT
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stacey Silvers Madison ENT
PRS Account Intersect ENT
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP