Nasal Obstruction, BilateralNCT04717791
Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing
A study testing Vivaer® ARC Stylus in people with Nasal Obstruction, Bilateral, run by HNO-Praxis Alte Post at 3 sites in Germany.
Trial summary
A Prospective, Multicenter, Non-Randomized Study of the Aerin Medical Vivaer ARC Stylus for Nasal Airway Obstruction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Obstruction, Bilateral
- What is being tested?
- Vivaer® ARC Stylus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesGermany
- Study dates
- 8 Sep 2020to 4 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
- -
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
HNO-ZENTRUM am Kudamm
Berlin, 10629
HNO-Praxis Alte Post
Göttingen, Niedersachen, 37073
HNO-Praxis
Lichtenfels, Bavaria, 96215
About this study
Official title: Low Temperature Controlled Radiofrequency Intranasal Remodeling Treatment of the Nasal Valve Area. A Multicentric Long-term Evaluation
A Prospective, Multicenter, Non-Randomized Study of the Aerin Medical Vivaer ARC Stylus for Nasal Airway Obstruction
Read the 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.
- Conditions
- Nasal Obstruction, Bilateral
- Being tested
- Vivaer® ARC Stylus
- Keywords
- nasal obstruction, nasal valve stenosis, nasal valve pathology
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivaer® ARC StylusDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Procedure | Other | Subjects will be followed from the Vivaer® treatment date out to 24 months post index procedure. Receives: Device: Vivaer® ARC Stylus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months, 6, 12 and 24 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 Months, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start8 Sep 2020
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Obstruction, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- HNO-Praxis Alte Post
- Sponsor type
- University, hospital or other
- Collaborators
- Aerin Medical
- Responsible party
- Principal investigator, Professor Dr. med. Detlef Brehmer, HNO-Praxis Alte Post
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717791
- Sponsor's protocol ID
- RFNV001
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Temperature Controlled Radiofrequency Intranasal Remodeling Treatment of the Nasal Valve Area. A Multicentric Long-term Evaluation
- ClinicalTrials.gov ID
- NCT04717791
- Acronym / sponsor ID
- RFNV001
- Conditions
- Nasal Obstruction, Bilateral
- Keywords
- nasal obstruction, nasal valve stenosis, nasal valve pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- HNO-Praxis Alte PostUniversity, hospital or other
- Collaborators
- Aerin Medical
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure | Other | Device: Vivaer® ARC StylusSubjects will be followed from the Vivaer® treatment date out to 24 months post index procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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):
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivaer® ARC StylusThe 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 | Device | Procedure |
Primary outcome
response rate Nose Score
Time frame: 3 Months, 6, 12 and 24 months
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.
2 secondary outcomes
Efficacy measurement using the change in mean NOSE SCORE
Time frame: 3 Months, 6, 12 and 24 months
Safety Control regarding
Time frame: 3 Months, 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Nasal Obstruction, Bilateral
Active, not recruiting
Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery
Sphenopalatine Ganglion Nerve Block, Transnasal Endoscopic Pitutary Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivaer® ARC Stylus in people with Nasal Obstruction, Bilateral, run by HNO-Praxis Alte Post at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate Nose Score (time frame: 3 Months, 6, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.