Chronic Rhinosinusitis (Diagnosis), Chronic Sinusitis
Conditions
Keywords
Balloon sinus dilation, Balloon catheters, Sinuplasty
Brief summary
A prospective, single-arm, post approval pilot study.
Detailed description
This study is evaluating transnasal sinus balloon dilation without tissue removal to treat the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic improvement post procedure.
Interventions
DEVICEBalloon sinus dilation
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
1. Be at least 18 years of age. 2. Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease. 3. Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis. 4. Have a CT scan within 6 months prior to enrollment. 5. Be mentally and physically capable (as per physician discretion) to participate in the investigation. 6. Be willing and able to sign the study-specific informed consent prior to any study-related procedures. 7. Be willing and able to undergo balloon dilation in the clinic setting.
Exclusion criteria
1. Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation. 2. Have presence of features consistent with sinus fungal disease. 3. Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum. 4. Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc). 5. Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty). 6. Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment. 7. Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract. 8. Have a history of primary ciliary dysfunction. 9. Have hemophilia. 10. Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region. 11. Have a history of cystic fibrosis. 12. Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis). 13. Have known sinonasal tumors or obstructive lesions. 14. Be pregnant at the time of enrollment. 15. Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5. 16. Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure. 17. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SNOT-20 Score | Baseline and 6 months post procedure | The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Time | 1 week post procedure | Patient-reported time from procedure to ability to return to normal daily activities. |
| Procedural Pain Scores | Immediately post procedure | Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant. |
| Revision Rate | 6 Months post procedure | The number of participants who require revision sinus surgery during the study duration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balloon Sinus Dilation Balloon dilation of the maxillary sinus using a transnasal approach.
Balloon sinus dilation | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Balloon Sinus Dilation |
|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 18 |
| Allergies (year-round or seasonal) | 16 Participants |
| Lund-Mackay score | 4.7 units on a scale STANDARD_DEVIATION 3.4 |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 9 Participants |
| Smoking status Nonsmokers | 19 Participants |
| Smoking status Smokers | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 1 / 21 |
Outcome results
Primary
SNOT-20 Score
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.
Time frame: Baseline and 6 months post procedure
Population: All participants with baseline and 6-month follow-up SNOT-20 assessments (matched pairs).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | SNOT-20 Score | Baseline | 2.3 score on a scale | Standard Deviation 0.8 |
| Balloon Sinus Dilation | SNOT-20 Score | 6-Month Follow-up | 0.8 score on a scale | Standard Deviation 0.6 |
p-value: <0.0001t-test, 2 sided
Secondary
Procedural Pain Scores
Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant.
Time frame: Immediately post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinus Dilation | Procedural Pain Scores | 1.8 score on a scale | Standard Deviation 1.8 |
Secondary
Recovery Time
Patient-reported time from procedure to ability to return to normal daily activities.
Time frame: 1 week post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinus Dilation | Recovery Time | 16.1 hours | Standard Deviation 17.8 |
Secondary
Revision Rate
The number of participants who require revision sinus surgery during the study duration.
Time frame: 6 Months post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balloon Sinus Dilation | Revision Rate | 0 Participants |