Sinusitis, Chronic Rhinosinusitis
Conditions
Brief summary
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
Interventions
DEVICEEthmoid Sinus Spacer
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 21 years old 2. Both male and female 3. Ethmoid disease on CT scan 4. At least one non-ethmoid sinus requiring treatment 5. Failed medical management and symptomatic
Exclusion criteria
1. Previous ethmoid surgery 2. Not sufficient room for placement of Spacer 3. Patient requires septoplasty 4. Has received steroid treatment with in 2 weeks 5. Extensive sinonasal osteoneogenesis preventing device placement 6. Sinonasal tumors or obstructive lesions 7. History of facial trauma that distorts sinus anatomy 8. Asthmatic patients with aspirin sensitivity 9. Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant | Procedural and 6 weeks post-implant |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures | 1 wk, 2wk, 4wk, 6wk |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ethmoid Sinus Spacer Placement Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Ethmoid Sinus Spacer Placement |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 50.1 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant
Time frame: Procedural and 6 weeks post-implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ethmoid Sinus Spacer Placement | Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant | 1 participants |
Secondary
Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures
Time frame: 1 wk, 2wk, 4wk, 6wk