Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device

Study Overview
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Brief Summary
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Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus

Detailed Description
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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.

Official Title
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A Prospective, Multi-Center, Non-Randomized Study to Evaluate the Quality of Life Impact After Treatment of Nasal Airway Obstruction Using the Aerin Medical Vivaer Stylus

Conditions
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Nasal Obstruction

Intervention / Treatment
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* Device: Vivaer Stylus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received nasal obstruction treatment in Aerin Study TP 258 Exclusion Criteria: Unwilling to participate in this long-term study

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long-Term Study Subjects<br>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. | Device: Vivaer Stylus<br>* Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus<br>* Other names: Aerin Medical Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 12, 18, 24 months post-procedure | 
| 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. | Update to include Extended Follow up to 36-, 48- months post-procedure | 
| 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. | 12, 18, 24 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal valve, Nasal airway obstruction, Quality of Life