Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

Nasal Obstruction, Bilateral Clinical Trial

Official title:

Low Temperature Controlled Radiofrequency Intranasal Remodeling Treatment of the Nasal Valve Area. A Multicentric Long-term Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04717791
• Other study ID #: RFNV001
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: October 4, 2022

Study information

• Verified date: January 2023
• Source: HNO-Praxis Alte Post
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Prospective, Multicenter, Non-Randomized Study of the Aerin Medical Vivaer ARC Stylus for Nasal Airway Obstruction

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: October 4, 2022
• Est. primary completion date: October 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Eligible subject will meet all the following:

• 1. 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):

• Use of external nasal dilator strips (e.g., Breathe Right Strips)

• Q-Tip test (manual intranasal lateralization)

• Use of nasal stents

• Cottle Maneuver (manual lateral retraction of the cheek)

Exclusion Criteria:

Eligible subjects will NOT meet any of the following:

1. Prior surgical treatment of the nasal valve

2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past six months

3. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.

4. Known or suspected to be pregnant or is lactating.

5. Any adjunctive surgical nasal procedure planned on the same day or within 24 months after the Vivaer procedure.

6. Current participation in any study or participation in any study less than 6 weeks before study date 1.

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Related Conditions & MeSH terms

• Nasal Obstruction
• Nasal Obstruction, Bilateral

Intervention

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

Locations

Country	Name	City	State
Germany	HNO-ZENTRUM am Kudamm	Berlin
Germany	HNO-Praxis Alte Post	Göttingen	Niedersachen
Germany	HNO-Praxis	Lichtenfels	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
HNO-Praxis Alte Post	Aerin Medical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Incidence (type and category) of adverse events overall and by follow-up interval.	3 Months, 6, 12 and 24 months
Other	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.	3 Months, 6, 12 and 24 months
Other	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.	3 Months, 6, 12 and 24 months
Primary	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.	3 Months, 6, 12 and 24 months
Secondary	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.	3 Months, 6, 12 and 24 months
Secondary	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.	3 Months, 6, 12 and 24 months