The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening following frontal sinus surgery in patients with chronic sinusitis.
This is a prospective, randomized, blinded, controlled, multicenter study enrolling two consecutive cohorts of up to 80 patients each (Propel Mini cohort followed by Propel Nova cohort). The study patients will undergo implant placement on one side following ESS that includes bilateral frontal sinus surgery by traditional surgical technique or balloon dilation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Placement of sinus implant following frontal sinus surgery
Sinus surgery only, without implant placement
Placement of sinus implant following frontal sinus surgery
Sacramento Ear, Nose and Throat
Sacramento, California, United States
Breathe Clear Institute of Sinus and Allergy Relief
Torrance, California, United States
The Connecticut Center for Advanced ENT Care
Norwalk, Connecticut, United States
Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
Time frame: Day 30
Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)
The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
Time frame: Day 30
Need for Post-operative Interventions (Propel Mini Cohort)
Need for post-operative interventions by clinical investigators at Day 30 Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
Time frame: Day 30
Need for Surgical Interventions (Propel Mini Cohort)
Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO 1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) 2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) 3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)
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George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
ENT of Georgia
Atlanta, Georgia, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Albany ENT and Allergy
Albany, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
East Virginia Medical School
Norfolk, Virginia, United States
Time frame: Day 30
Inflammation (Propel Mini Cohort)
The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.
Time frame: Day 30
Occlusion/Restenosis (Propel Mini Cohort)
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent 1. Restenosed/Partially Occluded 2. Occluded
Time frame: Day 30
Need for Post-operative Interventions (Propel Nova Cohort)
Need for post-operative interventions by clinical investigators at Day 30. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
Time frame: Day 30
Need for Surgical Interventions (Propel Nova Cohort)
Need for Surgical Interventions by clinical investigators at Day 30 Need for Surgical Interventions by clinical investigators at Day 30. Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3. Adhesions/Scarring was assessed based on a 4-point scale as follows: 0= No visible granulation/scarring in the FSO 1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) 2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) 3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)
Time frame: Day 30
Inflammation (Propel Nova Cohort)
The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.
Time frame: Day 30
Occlusion/Restenosis (Propel Nova Cohort)
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent 1. Restenosed/Partially Occluded 2. Occluded
Time frame: Day 30