An interventional study of Vivaer® ARC Stylus in Nasal Obstruction, Bilateral, sponsored by HNO-Praxis Alte Post. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by HNO-Praxis Alte Post · Not applicable, Interventional, and Treatment
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.
108 studies on the registry are indexed under Nasal Obstruction; 27 are open to participants now.
This study's enrollment of 118 is above the median of 52 across 80 interventional studies indexed under Nasal Obstruction.
Browse Nasal Obstruction studies →This is the only study on the registry with HNO-Praxis Alte Post as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Eligible subject will meet all the following:
Age 18 or older 2. Willing and able to provide informed consent 3. Willing and able to comply with the study protocol 4. Seeking treatment for nasal obstruction 5. NOSE score of ≥ 60 at Baseline 6. Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam):
Exclusion Criteria:
Eligible subjects will NOT meet any of the following:
Current participation in any study or participation in any study less than 6 weeks before study date 1.
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Subjects will be followed from the Vivaer® treatment date out to 24 months post index procedure.
Device: Vivaer® ARC Stylus
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
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
Adverse events
Incidence (type and category) of adverse events overall and by follow-up interval.
Time frame: 3 Months, 6, 12 and 24 months
Nasal Assessment
The target nasal valve area within each nostril will be visually assessed at baseline and following the treatment procedure at all evaluations. The use of an endoscope for visual assessment is required. Representative still photographs or video of each nostril will be captured at each visit.
Time frame: 3 Months, 6, 12 and 24 months
Medications
Self-reported assessment of an increase, no change, or decrease in medications and/or devices being used for treatment of nasal symptoms at each evaluation compared to use prior to the procedure.
Time frame: 3 Months, 6, 12 and 24 months
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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