Trial Outcomes & Findings for Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device (NCT NCT03290300)
NCT ID: NCT03290300
Last Updated: 2024-02-15
Results Overview
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.
Recruitment status
COMPLETED
Target enrollment
39 participants
Primary outcome timeframe
Baseline, 12, 18, 24 months post-procedure
Results posted on
2024-02-15
Participant Flow
Participant milestones
| Measure |
Long-Term Study Subjects
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study (NCT02914236), who consented to continue to provide quality of life data.
Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Long-Term Study Subjects
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study (NCT02914236), who consented to continue to provide quality of life data.
Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device
Baseline characteristics by cohort
| Measure |
Long-Term Study Subjects
n=39 Participants
This cohort will consist of all subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consent to continue to provide quality of life data.
Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus
|
|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 12.8 • n=113 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=113 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=113 Participants
|
|
Baseline NOSE Score
|
80.8 units on a scale
STANDARD_DEVIATION 10.7 • n=113 Participants
|
|
26-week NOSE Score (end of previous study)
|
24.9 units on a scale
STANDARD_DEVIATION 21.3 • n=113 Participants
|
|
Change in NOSE score from baseline to 26 weeks
|
55.9 units on a scale
STANDARD_DEVIATION 23.6 • n=113 Participants
|
|
26-week responder
|
36 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12, 18, 24 months post-procedurePopulation: The population evaluated at 12 months was 36, rather than the full 39 participants, since 3 subjects had not completed the consent process until after the 12-month post-procedure evaluation window. By the 24-month follow-up, 3 subjects had been lost to follow-up.
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.
Outcome measures
| Measure |
Long-Term Study Subjects - 12 Month Data
n=36 Participants
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and were enrolled in this study within the 12-month post-procedure window.
|
Long-Term Study Subjects - 18 Month Data
n=39 Participants
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 18-month post-procedure window.
|
Long-Term Study Subjects - 24 Month Data
n=36 Participants
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 24-month post-procedure window.
|
|---|---|---|---|
|
Change From Baseline NOSE Score
|
53.3 units on a scale
Standard Deviation 25.2
|
48.1 units on a scale
Standard Deviation 30.2
|
53.5 units on a scale
Standard Deviation 24.6
|
PRIMARY outcome
Timeframe: Update to include Extended Follow up to 36-, 48- months post-procedurePopulation: Of the 49 patients in the initial study,39 agreed to participate in follow-up through 24 months.
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.
Outcome measures
| Measure |
Long-Term Study Subjects - 12 Month Data
n=28 Participants
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and were enrolled in this study within the 12-month post-procedure window.
|
Long-Term Study Subjects - 18 Month Data
n=28 Participants
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 18-month post-procedure window.
|
Long-Term Study Subjects - 24 Month Data
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 24-month post-procedure window.
|
|---|---|---|---|
|
Change From Baseline NOSE Score - Long Term Extended Follow-up
|
32.3 score on a scale
Standard Deviation 21.4
|
25.7 score on a scale
Standard Deviation 19.1
|
—
|
PRIMARY outcome
Timeframe: 12, 18, 24 months post-procedurePopulation: Data missing for some questions not answered by subjects.
This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered "agree or agree strongly" when prompted with "Compared to before I had the Aerin Medical Nasal Procedure, I have experienced..." were considered to have a positive response. For questions 15-18, those who answered "rarely/very rarely/never" when prompted with "Compared to before you had the procedure, how often did you suffer from the following conditions?..." were considered to have a positive response. For questions 19-21, those who answered "less or much less frequently" when prompted with "Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?..." were considered to have a positive response.
Outcome measures
| Measure |
Long-Term Study Subjects - 12 Month Data
n=36 Participants
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and were enrolled in this study within the 12-month post-procedure window.
|
Long-Term Study Subjects - 18 Month Data
n=39 Participants
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 18-month post-procedure window.
|
Long-Term Study Subjects - 24 Month Data
n=36 Participants
This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 24-month post-procedure window.
|
|---|---|---|---|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q6: Increased productivity
|
13 Participants
|
16 Participants
|
21 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q1: Less difficulty falling asleep
|
25 Participants
|
22 Participants
|
28 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q2: Less waking up at night
|
20 Participants
|
25 Participants
|
25 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q3: Better sleep throughout the night
|
23 Participants
|
27 Participants
|
26 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q4: Waking up feeling rested
|
18 Participants
|
21 Participants
|
22 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q5: Less fatigue during the day
|
20 Participants
|
24 Participants
|
19 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q7: Increased energy
|
18 Participants
|
16 Participants
|
22 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q8: Increased ability to focus
|
11 Participants
|
18 Participants
|
22 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q9: Increased sense of overall well-being
|
18 Participants
|
21 Participants
|
23 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q10: Less feelings of frustration
|
17 Participants
|
21 Participants
|
18 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q11: Less feelings of sadness
|
12 Participants
|
13 Participants
|
17 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q12: Less feelings of embarrassment
|
20 Participants
|
13 Participants
|
16 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q13:Missing fewer activites with family/friends
|
12 Participants
|
13 Participants
|
17 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q14: Missing fewer days at work
|
9 Participants
|
8 Participants
|
15 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q15: Headaches
|
22 Participants
|
27 Participants
|
28 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q16: Sinus infections
|
28 Participants
|
32 Participants
|
33 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q17: Sore throat
|
30 Participants
|
33 Participants
|
30 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q18: Post nasal drip
|
19 Participants
|
19 Participants
|
21 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q19: Oral medications
|
23 Participants
|
19 Participants
|
24 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q20: Nasal sprays
|
26 Participants
|
20 Participants
|
23 Participants
|
|
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
Q21: Nasal breathing strips
|
22 Participants
|
27 Participants
|
29 Participants
|
Adverse Events
Long-Term Study Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Scott Wolf, M.D.; Chief Medical Officer
Aerin Medical, Inc.
Phone: 650-597-0111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee First publication of study results shall be made in conjunction with the results from all clinical study centers participating in the multicenter study. If results of the multi-center study have not been published in full within 18 months after completion of the study, investigator shall be free to publish results. Investigator agrees to submit all proposed publications to the sponsor at least 60 days prior submission; the company has the right to comment.
- Publication restrictions are in place
Restriction type: OTHER