Nasal Obstruction
Conditions
Keywords
Nasal valve, Nasal airway obstruction, Quality of Life
Brief summary
Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus
Detailed description
This is a prospective, non-randomized, multi-center follow-up study to collect long term quality of life (QOL) data on a cohort of patients who participated in the Aerin Medical TP258 study A Prospective, Multi-Center, Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device. The TP258 study followed subjects out to 26 weeks post-procedure. This QOL study will collect data at 12, 18, 24, 36, 48 and 60 months post-procedure.
Interventions
DEVICEVivaer Stylus
Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus
Sponsors
Aerin Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received nasal obstruction treatment in Aerin Study TP 258
Exclusion criteria
* Unwilling to participate in this long-term study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline NOSE Score | Baseline, 12, 18, 24 months post-procedure | 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. |
| Change From Baseline NOSE Score - Long Term Extended Follow-up | Update to include Extended Follow up to 36-, 48- months post-procedure | 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. |
| Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | 12, 18, 24 months post-procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Long-Term Study Subjects 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 | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Long-Term Study Subjects |
|---|---|
| 26-week NOSE Score (end of previous study) | 24.9 units on a scale STANDARD_DEVIATION 21.3 |
| 26-week responder | 36 Participants |
| Age, Continuous | 51.7 years STANDARD_DEVIATION 12.8 |
| Baseline NOSE Score | 80.8 units on a scale STANDARD_DEVIATION 10.7 |
| Change in NOSE score from baseline to 26 weeks | 55.9 units on a scale STANDARD_DEVIATION 23.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Change From Baseline NOSE Score
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.
Time frame: Baseline, 12, 18, 24 months post-procedure
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Long-Term Study Subjects - 12 Month Data | Change From Baseline NOSE Score | 53.3 units on a scale | Standard Deviation 25.2 |
| Long-Term Study Subjects - 18 Month Data | Change From Baseline NOSE Score | 48.1 units on a scale | Standard Deviation 30.2 |
| Long-Term Study Subjects - 24 Month Data | Change From Baseline NOSE Score | 53.5 units on a scale | Standard Deviation 24.6 |
p-value: <0.0001ANOVA
Primary
Change From Baseline NOSE Score - Long Term Extended 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.
Time frame: Update to include Extended Follow up to 36-, 48- months post-procedure
Population: Of the 49 patients in the initial study,39 agreed to participate in follow-up through 24 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Long-Term Study Subjects - 12 Month Data | Change From Baseline NOSE Score - Long Term Extended Follow-up | 32.3 score on a scale | Standard Deviation 21.4 |
| Long-Term Study Subjects - 18 Month Data | Change From Baseline NOSE Score - Long Term Extended Follow-up | 25.7 score on a scale | Standard Deviation 19.1 |
Primary
Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
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.
Time frame: 12, 18, 24 months post-procedure
Population: Data missing for some questions not answered by subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q8: Increased ability to focus | 11 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q1: Less difficulty falling asleep | 25 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q15: Headaches | 22 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q9: Increased sense of overall well-being | 18 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q4: Waking up feeling rested | 18 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q14: Missing fewer days at work | 9 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q10: Less feelings of frustration | 17 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q21: Nasal breathing strips | 22 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q13:Missing fewer activites with family/friends | 12 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q11: Less feelings of sadness | 12 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q19: Oral medications | 23 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q12: Less feelings of embarrassment | 20 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q5: Less fatigue during the day | 20 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q20: Nasal sprays | 26 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q18: Post nasal drip | 19 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q6: Increased productivity | 13 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q3: Better sleep throughout the night | 23 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q17: Sore throat | 30 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q7: Increased energy | 18 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q2: Less waking up at night | 20 Participants |
| Long-Term Study Subjects - 12 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q16: Sinus infections | 28 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q19: Oral medications | 19 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q1: Less difficulty falling asleep | 22 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q2: Less waking up at night | 25 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q3: Better sleep throughout the night | 27 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q4: Waking up feeling rested | 21 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q5: Less fatigue during the day | 24 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q6: Increased productivity | 16 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q7: Increased energy | 16 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q8: Increased ability to focus | 18 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q9: Increased sense of overall well-being | 21 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q10: Less feelings of frustration | 21 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q11: Less feelings of sadness | 13 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q12: Less feelings of embarrassment | 13 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q13:Missing fewer activites with family/friends | 13 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q14: Missing fewer days at work | 8 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q15: Headaches | 27 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q16: Sinus infections | 32 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q17: Sore throat | 33 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q18: Post nasal drip | 19 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q20: Nasal sprays | 20 Participants |
| Long-Term Study Subjects - 18 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q21: Nasal breathing strips | 27 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q8: Increased ability to focus | 22 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q2: Less waking up at night | 25 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q15: Headaches | 28 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q7: Increased energy | 22 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q21: Nasal breathing strips | 29 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q16: Sinus infections | 33 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q6: Increased productivity | 21 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q20: Nasal sprays | 23 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q17: Sore throat | 30 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q5: Less fatigue during the day | 19 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q1: Less difficulty falling asleep | 28 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q18: Post nasal drip | 21 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q11: Less feelings of sadness | 17 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q4: Waking up feeling rested | 22 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q12: Less feelings of embarrassment | 16 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q10: Less feelings of frustration | 18 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q3: Better sleep throughout the night | 26 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q13:Missing fewer activites with family/friends | 17 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q9: Increased sense of overall well-being | 23 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q19: Oral medications | 24 Participants |
| Long-Term Study Subjects - 24 Month Data | Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items | Q14: Missing fewer days at work | 15 Participants |