Sinusitis
Conditions
Keywords
Chronic rhinosinusitis, Chronic sinusitis, Maxillary sinus, Anterior ethmoid sinus, Ethmoid infundibulum, Balloon dilation, Endoscopic visualization, Local anesthesia, Canine fossa, Less invasive
Brief summary
This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.
Interventions
DEVICERS-Series Rhinosinusitis Treatment System
Single arm
DEVICEFinESS Balloon
Sponsors
Entellus Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects age 18 or older with chronic rhinosinusitis of the maxillary or maxillary and anterior ethmoid sinuses * A CT scan taken after maximal medical therapy (e.g., local or systemic antibiotics, topical steroids, etc.) must show one of the following: 1. Narrowing of the outflow tract of the maxillary sinus ostium or infundibulum with mucosal thickening of 2 mm or greater of the maxillary sinus antrum. 2. Evidence of maxillary sinus air/liquid level.
Exclusion criteria
* Evidence of chronic posterior ethmoid, sphenoid or frontal sinusitis * Inability to understand the study or a history of non-compliance with medical advice * Unwilling or unable to sign Informed Consent Form (ICF) * Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies) * History of any cognitive or mental health status that would interfere with study participation * Previous sinus surgery or intervention including sinuplasty * Pregnant women * Severe septal deviation causing obstruction of the ostiomeatal unit * History of primary ciliary dysfunction * Hemophilia * Currently undergoing or in the past 6 months had undergone chemotherapy for cancer or radiation therapy in the head or neck region * History of cystic fibrosis * Known Sampter's Triad (aspirin sensitivity, asthma, sinonasal polyposis) * Known sinonasal tumors or obstructive lesions * History of mid facial fractures or orthognathic surgery (does not include nasal fracture) * History of insulin dependent diabetes * Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio(INR) is below 1.5 * Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure * Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure * Presence of nasal polyps that may interfere with the treatment procedure * Presence of features consistent with sinus fungal disease on CT or physical examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidences of Device-related or Procedure-related Complications | Through 12 months post-procedure | — |
| Patency of the Treated Area as Verified by CT Scan | Post-treatment at 3 months | Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians. |
| Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement | Post-treatment through 12 months | Symptomatic change in SNOT 20 scores on a 5-point Likert scale where 0 = no problem to 5 = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful. |
Countries
United States
Participant flow
Recruitment details
Enrolled patients with chronic rhinosinusitis (CRS) from Ear, Nose Throat (ENT) physician practices.
Pre-assignment details
All patients had transantral balloon dilation of the maxillary sinus ostium and ethmoid infundibulum with the FinESS Sinus System.
Participants by arm
| Arm | Count |
|---|---|
| Balloon Dilation | 71 |
| Total | 71 |
Baseline characteristics
| Characteristic | Balloon Dilation |
|---|---|
| Age Continuous | 47.3 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment United States | 71 participants |
| Sex: Female, Male Female | 45 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 | 0 / 71 |
| serious Total, serious adverse events | 1 / 71 |
Outcome results
Primary
Incidences of Device-related or Procedure-related Complications
Time frame: Through 12 months post-procedure
Population: Patients completing 12 month follow-up
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Treatment Group (ALL) | Incidences of Device-related or Procedure-related Complications | 1 participants | 0.98 |
Primary
Patency of the Treated Area as Verified by CT Scan
Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.
Time frame: Post-treatment at 3 months
Population: Analysis of ostia patency done per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group (ALL) | Patency of the Treated Area as Verified by CT Scan | 106 Ostia |
Primary
Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement
Symptomatic change in SNOT 20 scores on a 5-point Likert scale where 0 = no problem to 5 = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful.
Time frame: Post-treatment through 12 months
Population: Score reduction in SNOT 20 Scale Scores. Baseline through 12 months post-procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group (ALL) | Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement | -1.8 Scores on a scale |