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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Chronic Sinusitis
Interventions Device: PROPEL Mini Sinus Implant
Procedure: Balloon Sinus Dilation Alone
Enrollment 50
Recruitment Details A total of 50 participants were recruited across 12 clinical sites.
Pre-assignment Details An intra-patient control design was employed where left and right frontal sinuses of each patient were randomized to the treatment or control group after successful completion of in-office balloon dilation.
Arm/Group Title PROPEL Mini Sinus Implant Balloon Sinus Dilation Alone
Hide Arm/Group Description Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) after a successful in-office balloon dilation Successful in-office balloon dilation of the frontal sinus ostia (FSO) without implant placement
Period Title: Overall Study
Number of participants Number of units (sinus sides) Number of participants Number of units (sinus sides)
Started 50 [1] 50 50 [2] 50
Completed 50 50 50 50
Not Completed 0 0 0 0
[1]
A total of 50 subjects with one sinus side assigned to the treatment group
[2]
A total of 50 subjects with one sinus side assigned to the control group
Arm/Group Title All Study Participants
Hide Arm/Group Description This study used an intra-patient design with each participant having one sinus side randomized to the treatment group and the other to the control group.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
56.3  (13.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
13
  26.0%
Male
37
  74.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 50 participants
White
49
  98.0%
Hispanic
0
   0.0%
Other
1
   2.0%
Black or African American
0
   0.0%
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or other Pacific Islander
0
   0.0%
Lund-Mackay Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants
10.8  (3.67)
[1]
Measure Description: The Lund-Mackay score is a method of radiologic staging of chronic rhinosinusitis based on computed tomography (CT) where each sinus is assigned a score of 0 (no abnormality), 1 (partial opacification), or 2 (complete opacification). The overall total score is the sum of scores from 6 sinuses on each side and ranges from 0 to 24 with higher score indicating greater disease burden.
Lund-MacKay Frontal Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants
1.2  (0.40)
[1]
Measure Description: The Lund-Mackay Frontal score is determined based on computed tomography (CT) of the frontal sinus on a 0 to 2 scale where 0 = no abnormality, 1 = partial opacification, and 2 = complete opacification. The frontal score is the sum of scores on the left and right side and ranges from 0 to 4 with higher score indicating greater disease burden.
1.Primary Outcome
Title Patency Rate
Hide Description 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.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome analyzed using the intent-to-treat population, which consisted of all randomized subjects and sinuses. Patency grade for 10 sinuses (6 treatment, 4 control) were missing as clinical investigators were unable to view the frontal recess/FSO, reducing the number of evaluable subjects to 44 in the treatment group and 46 in the control group.
Arm/Group Title PROPEL Mini Sinus Implant Balloon Sinus Dilation Alone
Hide Arm/Group Description:
Placement of the Propel Mini Sinus Implant in the frontal sinus ostia (FSO) after a successful in-office balloon dilation
Successful in-office bilateral balloon dilation of the frontal sinus ostia (FSO) without implant placement
Overall Number of Participants Analyzed 44 46
Overall Number of Units Analyzed
Type of Units Analyzed: Sinus sides
44 46
Count of Units
Unit of Measure: sinus sides
38
  86.4%
33
  71.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROPEL Mini Sinus Implant, Balloon Sinus Dilation Alone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0391
Comments P-value not adjusted for multiplicity.
Method McNemar
Comments McNemar’s exact binomial test was employed to obtain the two-sided p-value at alpha level of 0.05.
2.Secondary Outcome
Title Inflammation Score
Hide Description 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)
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Inflammation score for 7 sinuses (4 treatment, 3 control) were missing as clinical investigators were unable to view the frontal recess/FSO for 3 treatment and 2 control sinuses, and 1 participant with 1 treatment and 1 control sinuses was lost to follow-up.
Arm/Group Title PROPEL Mini Sinus Implant Balloon Sinus Dilation Alone
Hide Arm/Group Description:
Placement of Propel Mini Sinus Implant after a successful in-office balloon dilation of the frontal sinus ostia (FSO)
Successful in-office bilateral balloon dilation of the frontal sinus ostia (FSO) only without implant placement
Overall Number of Participants Analyzed 46 47
Overall Number of Units Analyzed
Type of Units Analyzed: Sinuses
46 47
Mean (Standard Deviation)
Unit of Measure: mm
43.2  (32.22) 45.8  (36.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROPEL Mini Sinus Implant, Balloon Sinus Dilation Alone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse event data were collected from enrollment through Day 180 post-procedure.
Adverse Event Reporting Description Adverse event data were collected by clinical investigators using MedDRA terms, organized by System Organ Class.
 
Arm/Group Title All Participants
Hide Arm/Group Description An intra-patient control design with placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation compared to in-office balloon dilation without implant placement of the contralateral frontal sinus ostia (FSO) assigned to the control group.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/50 (0.00%)    
Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   0/50 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%) # Events
Total   5/50 (10.00%)    
Infections and infestations   
Acute sinusitis  1  3/50 (6.00%)  3
Nervous system disorders   
Vision blurred  1  1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  1/50 (2.00%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
One limitation of this study design is utilizing an intra-patient control. This precludes evaluation of patient-reported outcomes. However, it also minimizes interpatient variability, and the differences in surgical techniques.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Stambaugh, Vice President of Clinical & Medical Affairs
Organization: Intersect ENT, Inc.
Phone: 650-641-2103
EMail: jstambaugh@intersectent.com
Layout table for additonal information
Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT02880514    
Other Study ID Numbers: P500-0616
First Submitted: August 18, 2016
First Posted: August 26, 2016
Results First Submitted: June 6, 2018
Results First Posted: December 10, 2018
Last Update Posted: December 10, 2018