A Prospective, Multicenter, Non-Randomized Study of the Aerin Medical Vivaer ARC Stylus for Nasal Airway Obstruction
The primary objective of this post-market study is to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction using validated questionaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
118
The Vivaer procedure will be performed in the study clinic using the VivAer Stylus and Aerin Console. The VivAer Stylus is a disposable handheld device capable of delivering low-temperature bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nasal valves treated in a single study procedure session. Each nostril will be treated at up to 3 positions
HNO-Praxis
Lichtenfels, Bavaria, Germany
HNO-Praxis Alte Post
Göttingen, Niedersachen, Germany
HNO-ZENTRUM am Kudamm
Berlin, Germany
response rate Nose Score
The primary efficacy endpoint is the responder rate at 3 months after the procedure for the participants. Individual participant success (responder) is defined as at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class improvement or an improvement (decrease) in NOSE score of 20% or more from baseline at the 3-month evaluation.
Time frame: 3 Months, 6, 12 and 24 months
Efficacy measurement using the change in mean NOSE SCORE
Efficacy measurement using the change in mean NOSE SCORE from baseline to the 3-month evaluation. The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity.
Time frame: 3 Months, 6, 12 and 24 months
Safety Control regarding
Safety Control regarding the frequency of device-related and procedure-related adverse events. All adverse events will be analyzed for all participants. Adverse events will be coded using a custom Aerin Medical dictionary so that adverse events may be categorized for analysis at an appropriate level of detail. Listings will be provided to detail individual events. The number of participants, number of AEs, and the proportion of participants reporting each AE will be summarized. Seriousness and severity of AEs and their relationship to the device and procedure will be summarized. A time course of adverse events will be presented. Any unexpected adverse device experiences or adverse events that occur at an unexpectedly high incidence rate will receive detailed analyses. Narratives will be presented for all deaths, serious adverse events, unexpected adverse device experiences, and participants withdrawn due to an adverse event.
Time frame: 3 Months, 6, 12 and 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.