Chronic Sinusitis
Conditions
Keywords
Chronic Sinusitis, Endoscopic Sinus Surgery
Brief summary
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia.
Detailed description
This is a prospective, single-center, single-arm, open label feasibility study aiming to enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. The objective of this feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis (CS) patients undergoing sinus surgery of peripheral sinus ostia.
Interventions
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
Sponsors
Intersect ENT
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Propel Nova Sinus Implant
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is ≥ 18 years of age. * Patient is willing and able to comply with protocol requirements. * Patient has CS as confirmed by CT scan and defined as symptoms lasting longer than 8 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses. * Patient's condition and the planned intervention will involve at least two and a maximum of four peripheral sinuses (frontal or maxillary sinuses or combination of both). * Patient is a candidate for a planned intervention involving sinus surgery in the operating room or office setting. * Patient has nasal polyps no greater than grade 2. * Patient with nasal polyps greater than 2 are eligible after their reduction/removal during ESS without significant complications that would confound the study results and leaving the patient's anatomy amenable to sinus implant placement, as judged by the operating physician. * Female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study. * Female patients of child-bearing potential must agree to use consistent and acceptable method/s of birth control during the course of the study. * CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure. * Patient has a minimum total CT stage (Lund-Mackay method) of 6. * Patient has disease in frontal and/or maxillary sinuses confirmed by CT scan. * Planned ESS includes bilateral ethmoidectomy (if judged necessary), frontal sinus surgery using Draf II (A or B) dissection and/or balloon dilation, with minimum of 5-mm diameter opening created. In the case of maxillary sinus surgery, traditional antrostomy or balloon dilation, with or without removal of uncinate process, should be performed with minimum of 5-mm diameter opening created. * Technique used for frontal or maxillary sinus surgery was 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.
Exclusion criteria
* Patient has presence of grade 3 or 4 polyposis, unless removed during surgery and preceding implant placement. * Patient has presence of adhesions/scarring grades 3 or 4, unless removed during surgery and preceding implant placement. * Patient has known history of immune deficiency (e.g., IGG subclass deficiency or IGA deficiency, HIV). * Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.). * Patient has oral-steroid dependent condition such as COPD, asthma or other condition. * Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate. * Patient has clinical evidence of acute bacterial sinusitis (e.g. acute increase in purulent discharge, fever, facial pain etc.). * Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue, etc.). * Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day period. * Patient is currently participating in another clinical trial. * Patient has history of insulin dependent diabetes mellitus. * Patient has previously undergone ESS and experienced a CSF leak or has residual compromised vision as a result of a complication in a prior ESS procedure. * Patient has known dehiscence of the lamina papyracea. * Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes simplex, chickenpox or measles). * Significant complication during the current peripheral ostia surgery/such as excessive blood loss, CSF leak or punctured lamina papyracea. * Current surgical intervention (operating room or office setting) is aborted for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Placement Success Rate | Baseline Procedure | Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ostial Patency | Baseline, Day 30, Day 90 | Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed) |
| Adhesion/Scarring Grade 2 & 3 | Baseline, Day 30, Day 90 | Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium) |
| Degree of Inflammation | Baseline, Day 30, Day 90 | 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) |
| Sino-Nasal Outcome Test (SNOT) 22 | Baseline, Day 30, Day 90 | Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Propel Nova Sinus Implant Steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Open Label - Day 30 | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Propel Nova Sinus Implant |
|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 13.24 |
| Lund-Mackay Score (CT scan) Frontal Sinuses | 2.5 units on a scale STANDARD_DEVIATION 1.19 |
| Lund-Mackay Score (CT scan) Maxillary Sinuses | 2.3 units on a scale STANDARD_DEVIATION 0.98 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
Primary
Device Placement Success Rate
Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.
Time frame: Baseline Procedure
Population: Attempted frontal and maxillary sinus ostia
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Propel Nova Sinus Implant | Device Placement Success Rate | Frontal Sinuses | 100 Percentage of attempted sinuses |
| Propel Nova Sinus Implant | Device Placement Success Rate | Maxillary Sinuses | 95.2 Percentage of attempted sinuses |
Secondary
Adhesion/Scarring Grade 2 & 3
Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)
Time frame: Baseline, Day 30, Day 90
Population: Frontal and maxillary sinus ostia
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Propel Nova Sinus Implant | Adhesion/Scarring Grade 2 & 3 | Baseline - Frontal Sinuses | 33.4 percentage of evaluable sinuses |
| Propel Nova Sinus Implant | Adhesion/Scarring Grade 2 & 3 | Day 30 - Frontal Sinuses | 4.5 percentage of evaluable sinuses |
| Propel Nova Sinus Implant | Adhesion/Scarring Grade 2 & 3 | Day 90 - Frontal Sinuses | 11.8 percentage of evaluable sinuses |
| Propel Nova Sinus Implant | Adhesion/Scarring Grade 2 & 3 | Baseline - Maxillary Sinuses | 19.1 percentage of evaluable sinuses |
| Propel Nova Sinus Implant | Adhesion/Scarring Grade 2 & 3 | Day 30 - Maxillary Sinuses | 0 percentage of evaluable sinuses |
| Propel Nova Sinus Implant | Adhesion/Scarring Grade 2 & 3 | Day 90 - Maxillary Sinuses | 5.3 percentage of evaluable sinuses |
Secondary
Degree of Inflammation
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: Baseline, Day 30, Day 90
Population: Frontal and maxillary sinus ostia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Propel Nova Sinus Implant | Degree of Inflammation | Baseline - Frontal Sinuses | 62.8 units on a scale | Standard Deviation 23.14 |
| Propel Nova Sinus Implant | Degree of Inflammation | Day 30 - Frontal Sinuses | 28.1 units on a scale | Standard Deviation 23.24 |
| Propel Nova Sinus Implant | Degree of Inflammation | Day 90 - Frontal Sinuses | 25.0 units on a scale | Standard Deviation 25.23 |
| Propel Nova Sinus Implant | Degree of Inflammation | Baseline - Maxillary Sinuses | 51.6 units on a scale | Standard Deviation 24.94 |
| Propel Nova Sinus Implant | Degree of Inflammation | Day 30 - Maxillary Sinuses | 22.2 units on a scale | Standard Deviation 13.55 |
| Propel Nova Sinus Implant | Degree of Inflammation | Day 90 - Maxillary Sinuses | 14.1 units on a scale | Standard Deviation 21.6 |
Secondary
Ostial Patency
Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)
Time frame: Baseline, Day 30, Day 90
Population: Frontal and maxillary sinus ostia
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Propel Nova Sinus Implant | Ostial Patency | Baseline - Frontal Sinuses | 33.3 percentage of evaluable sinuses |
| Propel Nova Sinus Implant | Ostial Patency | Day 30 - Frontal Sinuses | 100 percentage of evaluable sinuses |
| Propel Nova Sinus Implant | Ostial Patency | Day 90 - Frontal Sinuses | 88.2 percentage of evaluable sinuses |
| Propel Nova Sinus Implant | Ostial Patency | Baseline - Maxillary Sinuses | 57.1 percentage of evaluable sinuses |
| Propel Nova Sinus Implant | Ostial Patency | Day 30 - Maxillary Sinuses | 100 percentage of evaluable sinuses |
| Propel Nova Sinus Implant | Ostial Patency | Day 90 - Maxillary Sinuses | 94.1 percentage of evaluable sinuses |
Secondary
Sino-Nasal Outcome Test (SNOT) 22
Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110
Time frame: Baseline, Day 30, Day 90
Population: Adult patients (≥ 18 years of age) diagnosed with chronic sinusitis with or without nasal/sinus polyposis who are candidates for endoscopic sinus surgery and in whom placement of the Propel Nova Sinus Implant is both feasible and medically appropriate
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Propel Nova Sinus Implant | Sino-Nasal Outcome Test (SNOT) 22 | Baseline | 42.6 units on a scale | Standard Deviation 14.9 |
| Propel Nova Sinus Implant | Sino-Nasal Outcome Test (SNOT) 22 | Day 30 | 21.5 units on a scale | Standard Deviation 19 |
| Propel Nova Sinus Implant | Sino-Nasal Outcome Test (SNOT) 22 | Day 90 | 20.6 units on a scale | Standard Deviation 19.3 |