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

Phase 3

Completed

Conditions: Chronic Sinusitis

Interventions: Procedure: Sinus Surgery alone
Device: Propel Nova Sinus Implant
Device: PROPEL Mini Sinus Implant.

Registration Number: NCT02266810

Lead Sponsor: Intersect ENT

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 160

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sinus Surgery alone: cohort 1	Sinus Surgery alone	Sinus Surgery only: cohort 1: ESS with standard post-operative care.
PROPEL Nova Sinus Implant	Propel Nova Sinus Implant	Propel Nova placed in frontal sinus opening following ESS
Sinus Surgery alone: cohort 2	Sinus Surgery alone	Sinus Surgery only: cohort 2: ESS with standard post-operative care.
PROPEL Mini Sinus Implant	PROPEL Mini Sinus Implant.	Propel Mini placed in frontal sinus opening following ESS

Primary Outcome Measures

Name	Time	Method
Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)	Day 30	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).
Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)	Day 30	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).

Secondary Outcome Measures

Name	Time	Method
Inflammation (Propel Mini Cohort)	Day 30	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.
Occlusion/Restenosis (Propel Mini Cohort)	Day 30	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
Need for Post-operative Interventions (Propel Mini Cohort)	Day 30	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).
Need for Surgical Interventions (Propel Mini Cohort)	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)
Need for Post-operative Interventions (Propel Nova Cohort)	Day 30	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).
Need for Surgical Interventions (Propel Nova Cohort)	Day 30	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)
Inflammation (Propel Nova Cohort)	Day 30	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.
Occlusion/Restenosis (Propel Nova Cohort)	Day 30	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

Trial Locations

Locations (10): Breathe Clear Institute of Sinus and Allergy Relief
🇺🇸
Torrance, California, United States
University of Texas Health Science Center at Houston
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Houston, Texas, United States
The Connecticut Center for Advanced ENT Care
🇺🇸
Norwalk, Connecticut, United States
ENT of Georgia
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Atlanta, Georgia, United States
East Virginia Medical School
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Norfolk, Virginia, United States
Oregon Health and Science University
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Portland, Oregon, United States
Sacramento Ear, Nose and Throat
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Sacramento, California, United States
Advanced ENT and Allergy
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Louisville, Kentucky, United States
Albany ENT and Allergy
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Albany, New York, United States
George Washington University Medical Faculty Associates
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Washington, District of Columbia, United States