Chronic Sinusitis
Conditions
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.
Interventions
DEVICEPROPEL Mini Sinus Implant.
Placement of sinus implant following frontal sinus surgery
PROCEDURESinus Surgery alone
Sinus surgery only, without implant placement
Placement of sinus implant following frontal sinus surgery
Sponsors
Advance Research Associates
Intersect ENT
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Intra-patient control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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). |
| 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 |
| 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) |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PROPEL Mini Sinus Implant and No Implant Cohort 1 This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.
PROPEL Mini or Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery | 80 |
| PROPEL Nova Sinus Implant and No Implant Cohort 2 This study will use an intra-patient design. Each patient will undergo placement of one implant. The untreated side will represent the control. The side of placement will be randomly assigned.
PROPEL Mini or Nova Sinus Implant.: Placement of sinus implant following frontal sinus surgery | 80 |
| Total | 160 |
Baseline characteristics
| Characteristic | PROPEL Mini Sinus Implant and No Implant Cohort 1 | Total | PROPEL Nova Sinus Implant and No Implant Cohort 2 |
|---|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 13.91 | 49.7 years STANDARD_DEVIATION 13.6 | 49.5 years STANDARD_DEVIATION 13.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 157 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 21 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 62 Participants | 130 Participants | 68 Participants |
| Region of Enrollment United States | 80 participants | 160 participants | 80 participants |
| Sex: Female, Male Female | 34 Participants | 61 Participants | 27 Participants |
| Sex: Female, Male Male | 46 Participants | 99 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 80 | 36 / 80 |
| serious Total, serious adverse events | 3 / 80 | 1 / 80 |
Outcome results
Primary
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
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROPEL Mini Sinus Implant | Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort) | 38.8 percent sinuses requiring intervention |
| Sinus Surgery Only: Cohort 1 | Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort) | 62.7 percent sinuses requiring intervention |
Primary
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
Population: Of the 80 patients who had their endoscopy recorded at day 30 for grading by independent reviewer; 19 patients could not be included in the test due to missing data. Data were considered missing if the independent reviewer could not grade a video on one or both treatment sinus sides.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROPEL Mini Sinus Implant | Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort) | 11.5 percentage sinus requiring intervention |
| Sinus Surgery Only: Cohort 1 | Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort) | 32.8 percentage sinus requiring intervention |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROPEL Mini Sinus Implant | Inflammation (Propel Mini Cohort) | 24.7 100-mm VAS | Standard Deviation 27.02 |
| Sinus Surgery Only: Cohort 1 | Inflammation (Propel Mini Cohort) | 41.3 100-mm VAS | Standard Deviation 29.34 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROPEL Mini Sinus Implant | Inflammation (Propel Nova Cohort) | 23.1 100-mm VAS | Standard Deviation 24.23 |
| Sinus Surgery Only: Cohort 1 | Inflammation (Propel Nova Cohort) | 35.6 100-mm VAS | Standard Deviation 31.12 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROPEL Mini Sinus Implant | Need for Post-operative Interventions (Propel Mini Cohort) | 16.5 percentage of evaluable sinuses |
| Sinus Surgery Only: Cohort 1 | Need for Post-operative Interventions (Propel Mini Cohort) | 41.8 percentage of evaluable sinuses |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROPEL Mini Sinus Implant | Need for Post-operative Interventions (Propel Nova Cohort) | 16.0 percentage of evaluable sinuses |
| Sinus Surgery Only: Cohort 1 | Need for Post-operative Interventions (Propel Nova Cohort) | 33.3 percentage of evaluable sinuses |
Secondary
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)
Time frame: Day 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROPEL Mini Sinus Implant | Need for Surgical Interventions (Propel Mini Cohort) | 4.0 percentage of evaluable sinuses |
| Sinus Surgery Only: Cohort 1 | Need for Surgical Interventions (Propel Mini Cohort) | 16.0 percentage of evaluable sinuses |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROPEL Mini Sinus Implant | Need for Surgical Interventions (Propel Nova Cohort) | 4.0 percentage of evaluable sinuses |
| Sinus Surgery Only: Cohort 1 | Need for Surgical Interventions (Propel Nova Cohort) | 14.7 percentage of evaluable sinuses |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROPEL Mini Sinus Implant | Occlusion/Restenosis (Propel Mini Cohort) | 21.1 percentage of evaluable sinuses |
| Sinus Surgery Only: Cohort 1 | Occlusion/Restenosis (Propel Mini Cohort) | 46.1 percentage of evaluable sinuses |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROPEL Mini Sinus Implant | Occlusion/Restenosis (Propel Nova Cohort) | 13.3 percentage of evaluable sinuses |
| Sinus Surgery Only: Cohort 1 | Occlusion/Restenosis (Propel Nova Cohort) | 36.0 percentage of evaluable sinuses |