Clinical trial NCT04717791: Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing
Official title: Low Temperature Controlled Radiofrequency Intranasal Remodeling Treatment of the Nasal Valve Area. A Multicentric Long-term Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction, Bilateral
Keywords: nasal obstruction
nasal valve stenosis
nasal valve pathology
Lead sponsor: HNO-Praxis Alte Post
Sponsor class: OTHER
Collaborators: name: Aerin Medical
First posted: 2021-01-22
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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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Primary outcomes:
measure: response rate Nose Score
timeFrame: 3 Months, 6, 12 and 24 months
Secondary outcomes:
measure: Efficacy measurement using the change in mean NOSE SCORE
timeFrame: 3 Months, 6, 12 and 24 months
measure: Safety Control regarding
timeFrame: 3 Months, 6, 12 and 24 months
Other outcomes:
measure: Adverse events
timeFrame: 3 Months, 6, 12 and 24 months
measure: Nasal Assessment
timeFrame: 3 Months, 6, 12 and 24 months
measure: Medications
timeFrame: 3 Months, 6, 12 and 24 months
Locations:
city: Lichtenfels
country: Germany
facility: HNO-Praxis
state: Bayern
city: Göttingen
country: Germany
facility: HNO-Praxis Alte Post
state: Niedersachen
city: Berlin
country: Germany
facility: HNO-ZENTRUM am Kudamm
Study officials:
References: