Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The PROGRESS Study: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implants Following Surgical Opening of the Frontal Sinus for Chronic Sinusitis: A Randomized Blinded Controlled Study

Conditions
-----------------
Chronic Sinusitis

Intervention / Treatment
-----------------
* Device: PROPEL Mini Sinus Implant.
* Procedure: Sinus Surgery alone
* Device: Propel Nova Sinus Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has CRS confirmed by CT scan and defined as symptoms lasting longer than 12 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses. Patient has a clinical indication for and has consented to ESS including bilateral frontal sinus surgery. Chronic sinusitis diagnosis confirmed and documented by CT scan within 6 months of the procedure. Patient has bilateral disease in both frontal sinuses confirmed by Lund-Mackay score of ≥1 on each side. Planned sinus surgery includes bilateral ethmoidectomy (if judged necessary) and frontal sinus enlargement using Draf II (A or B) dissection or balloon dilation, with minimum of 5-mm diameter opening created. Technique used for frontal sinus surgery is the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally) Septoplasty for access to the ostio-meatal complex is permitted. ESS including bilateral frontal sinus surgery 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. Exclusion Criteria: Known history of immune deficiency such as immunoglobin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV) Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or asthma or other condition Known history of allergy or intolerance to corticosteroids or mometasone furoate Clinical evidence of acute bacterial sinusitis Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue) Active viral illness Concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day follow-up period Currently participating in another clinical trial History of insulin dependent diabetes mellitus Patient has previously undergone ESS and experienced a CSF leak or has compromised vision as a result of a complication in a prior ESS procedure Significant complication during the current frontal sinus surgery procedure such as excessive blood loss, CSF leak or punctured lamina papyracea Current ESS including frontal sinus surgery is aborted for any reason. At least one side is not amenable for implant placement.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intra-patient control
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROPEL Mini Sinus Implant<br>Propel Mini placed in frontal sinus opening following ESS | Device: PROPEL Mini Sinus Implant.<br>* Placement of sinus implant following frontal sinus surgery<br>|
| Active Comparator: Sinus Surgery alone: cohort 1<br>Sinus Surgery only: cohort 1: ESS with standard post-operative care. | Procedure: Sinus Surgery alone<br>* Sinus surgery only, without implant placement<br>|
| Experimental: PROPEL Nova Sinus Implant<br>Propel Nova placed in frontal sinus opening following ESS | Device: Propel Nova Sinus Implant<br>* Placement of sinus implant following frontal sinus surgery<br>* Other names: PROPEL contour Sinus Implant;|
| Active Comparator: Sinus Surgery alone: cohort 2<br>Sinus Surgery only: cohort 2: ESS with standard post-operative care. | Procedure: Sinus Surgery alone<br>* Sinus surgery only, without implant placement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed) | 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. | 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 Restenosed/Partially Occluded Occluded | 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). | 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 Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed) | 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. | 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 Restenosed/Partially Occluded Occluded | Day 30 |