Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

NCT04717791 | Completed

• 1 other identifier: RFNV001
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Nasal Obstruction, Bilateral

Keywords

nasal obstruction; nasal valve stenosis; nasal valve pathology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Efficacy measurement using the change in mean NOSE SCORE

  3 Months, 6, 12 and 24 months

• Safety Control regarding

  3 Months, 6, 12 and 24 months

Other Outcomes (3)

• Adverse events

  3 Months, 6, 12 and 24 months

• Nasal Assessment

  3 Months, 6, 12 and 24 months

• Medications

  3 Months, 6, 12 and 24 months

Study Arms (1)

Procedure

OTHER

Subjects will be followed from the Vivaer® treatment date out to 24 months post index procedure.

Device: Vivaer® ARC Stylus

Interventions

Vivaer® ARC Stylus DEVICE

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

Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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)

You may not qualify if:

• Eligible subjects will NOT meet any of the following:
• Prior surgical treatment of the nasal valve
• Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past six months
• Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
• Known or suspected to be pregnant or is lactating.
• Any adjunctive surgical nasal procedure planned on the same day or within 24 months after the Vivaer procedure.
• Current participation in any study or participation in any study less than 6 weeks before study date 1.

Sponsors & Collaborators

• HNO-Praxis Alte Post: lead
• Aerin Medical: collaborator

Study Sites (3)

HNO-Praxis

Lichtenfels, Bavaria, 96215, Germany

Location

HNO-Praxis Alte Post

Göttingen, Niedersachen, 37073, Germany

Location

HNO-ZENTRUM am Kudamm

Berlin, 10629, Germany

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI Prof. Dr. med. Detlef Brehmer

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 22, 2021
• Study Start: September 8, 2020
• Primary Completion: October 4, 2022
• Study Completion: October 4, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)