N/A
N=39
Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device
Nasal Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT03290300 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change From Baseline NOSE Score — 53.3; 48.1; 53.5 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Vivaer Stylus (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Aerin Medical
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline NOSE Score |
53.3; 48.1; 53.5 | <0.0001 sig |
| PRIMARY Change From Baseline NOSE Score - Long Term Extended Follow-up |
32.3; 25.7 | — |
| PRIMARY Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items |
25; 22; 28; 20; 25; 25 | — |
Summary
Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus
Eligibility Criteria
Inclusion Criteria
- Received nasal obstruction treatment in Aerin Study TP 258
Exclusion Criteria
- Unwilling to participate in this long-term study
Data sourced from ClinicalTrials.gov (NCT03290300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.