Chronic Sinusitis
Conditions
Keywords
Patients diagnosed with Chronic Sinusitis undergoing functional endoscopic surgery (FESS)
Brief summary
This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).
Interventions
DEVICESteroid-Eluting Sinexus Intranasal Splint
Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Sponsors
Intersect ENT
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is 18 years of age or older * Patient has a diagnosis of chronic sinusitis * Patient has a clinical indication for and has consented to FESS * Patient CT scan confirms CS diagnosis within 6 months of procedure * CT sacn confirms presence of disease in ethmoid sinus(es) * Planned FESS includes unilateral or bilateral total ethmoidectomy
Exclusion criteria
* Immune deficiency (IGG subclass deficiency or IGA deficiency) * Oral-steroid dependent COPD, asthma or other condition * Clinical evidence of acute bacterial sinusitis * History or diagnosis of glaucoma or ocular hypertension * Clinical evidence or suspicion of invasive fungal sinusitis * Evidence of disease or condition expected to compromise survival or ability to complete follow-up * Known history of allergy or intolerance to corticosteroids * History of insulin dependent diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) | 30 days | — |
| Device Placement Success Rate | At the time of procedure | A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities | Baseline and 30 days | Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified. |
| Number of Sinuses With Significant Post-operative Adhesion Formation | 30 days | Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sinexus Intranasal Splint Patient receives a drug-coated intranasal splint
Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS) | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Sinexus Intranasal Splint |
|---|---|
| Age, Continuous | 44.2 years STANDARD_DEVIATION 13.1 |
| Lund MacKay CT Stage | 11.2 units on a scale STANDARD_DEVIATION 5.5 |
| Proportion of Patients Undergoing Revision Surgery | 14 participants |
| Proportion of Patients with Polyps | 33 participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 50 |
| serious Total, serious adverse events | 3 / 50 |
Outcome results
Primary
Device Placement Success Rate
A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.
Time frame: At the time of procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sinexus Intranasal Splint | Device Placement Success Rate | 90 Sinuses |
Primary
Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sinexus Intranasal Splint | Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) | 6 Number of Sinuses |
Secondary
Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities
Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.
Time frame: Baseline and 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sinexus Intranasal Splint | Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities | 0 Pts. w/ significant IOP elevation |
Secondary
Number of Sinuses With Significant Post-operative Adhesion Formation
Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sinexus Intranasal Splint | Number of Sinuses With Significant Post-operative Adhesion Formation | 1 sinuses |