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Chronic RhinitisRELIEFNCT04614324

A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF)

A study testing RhinAer ARC Stylus in people with Chronic Rhinitis, run by Aerin Medical at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Rhinitis
What is being tested?
RhinAer ARC Stylus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
15 sitesin 2 countries
Study dates
5 Oct 2020to 20 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 to 85 years (inclusively).
  • Willing and able to provide informed consent.
  • Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
  • Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure.
  • Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea).
  • Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion).
  • rTNSS ≥ 6.

Who cannot join

  • Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
  • Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.
  • Active nasal or sinus infection.
  • History of significant dry eye.
  • History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation.
  • Have rhinitis symptoms only on a seasonal basis due to allergies.
Show all 13Show fewer
  • Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
  • Known or suspected to be pregnant or is lactating.
  • Participating in another clinical research study.
  • Has any condition that predisposes to excessive bleeding.
  • Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure.
  • Has previous procedure or surgery for chronic rhinitis.
  • Other medical conditions which in the opinion of the investigator would predispose the subject to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States12 sites
  • Baton Rouge General / Sinus and Nasal Specialists of Louisiana

    Baton Rouge, Louisiana, 70809

  • ENT Associates of South Florida

    Boca Raton, Florida, 33487

  • Chicago Nasal and Sinus Center

    Chicago, Illinois, 60602

  • Fort Worth ENT

    Fort Worth, Texas, 76109

  • Arizona Desert ENT Specialists

    Goodyear, Arizona, 85395

  • Advanced ENT and Allergy

    Louisville, Kentucky, 40220

  • ENT and Allergy Associates of Texas

    McKinney, Texas, 75070

  • ENT and Allergy Associates of Florida

    Port Saint Lucie, Florida, 34952

  • Sacramento ENT

    Roseville, California, 95661

  • University of California, San Francisco

    San Francisco, California, 94115

  • Florida ENT and Allergy

    Tampa, Florida, 33619

  • Piedmont ENT Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany3 sites
  • HNO-ZENTRUM am Kudamm

    Berlin

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden

  • Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen

    Göttingen

Other trials in Germany

About this study

Official title: A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis

Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.

Read the detailed description

Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® ARC Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® ARC Stylus for treating the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis.

Being tested
RhinAer ARC Stylus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RhinAer ARC StylusDevice

    The RhinAer procedure incorporates use of the RhinAer Stylus (Model FG815), which is a cleared (FDA - K192471) disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. RhinAer has CE Marking in EU. The Aerin Console (Model FG226) RF generator with temperature control capable of delivering very low doses of energy was cleared for use in the US (FDA - K162810) and has CE Marking in the EU (CE639608).

Study groups in NCT04614324
Study groupRoleWhat they receive
RhinAer ARC Stylus TreatmentExperimentalThe RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nostrils treated in the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve.
Receives: Device: RhinAer ARC Stylus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)

    The rTNSS (Total Nasal Symptom Score) is a brief questionnaire developed to assess the severity of symptoms in individuals with rhinitis, particularly allergic rhinitis

    The questionnaire consists of questions that evaluate the following 4 symptoms of Nasal Congestion, Runny Nose, Nasal Itching and Sneezing.

    Each symptom is rated on a 4-point scale from "0" (no symptoms), "1" (mild symptoms), "2" (moderate symptoms" and "3" (severe symptoms). The total score is calculated by summing up the individual scores for each symptom.

    The total score is the sum of the 4 nasal symptoms.

    A low score indicates lower symptoms, a higher score indicates more symptoms. Range of score is 0-12 This questionnaire was provided to subjects at baseline and again at 3 months post procedure. This outcome measure shows the difference in overall scores. The average change in the score between baseline and 3M

    Measured: Baseline and 3 months post study procedure

Secondary outcomes (7)
  1. Participant Responder Percentage

    The rTNSS (Total Nasal Symptom Score) is a brief questionnaire developed to assess the severity of symptoms in individuals with rhinitis, particularly allergic rhinitis

    The questionnaire consists of questions that evaluate the following symptoms of Nasal Congestion, Runny Nose, Nasal Itching and Sneezing.

    Each symptom is rated on a 4-point scale from "0" (no symptoms) to "3" (severe symptoms). The total score is calculated by summing up the individual scores for each symptom.

    The total score is the sum of the 4 nasal symptoms.

    A low score indicates lower symptoms, a higher score indicates more symptoms. This questionnaire was provided to subjects at baseline and again at 3 months post procedure. This outcome measure shows the percentage of participants who responded to the procedure with improved rTNSS score

    Measured: Baseline and 3 months post study procedure

  2. 3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)

    The Rhinoconjuctivitis Quality of Life Questionnaire is validated rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated for efficiency by reducing the number of questions to 14.

    The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale:

    • 0 = not troubled
    • 1 = hardly troubled at all
    • 2 = somewhat troubled
    • 3 = moderately troubled
    • 4 = quite a bit troubled
    • 5 = very troubled
    • 6 = extremely troubled.

    The total or overall MiniRQLQ score is the mean of the 14 responses (range of 0-6). Developers of the original RQLQ reported MCID for overall miniRQLQ >0.7 with another study indicating 0.42 (95% CI 0.30-0.51).

    Measured: Baseline and 3 months post study procedure

  3. 6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)

    The Rhinoconjuctivitis Quality of Life Questionnaire is a well-established, validated, and the most frequently used rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated to further facilitate ease of use and efficiency by reducing the number of questions to 14.

    The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale:

    • 0 = not troubled
    • 1 = hardly troubled at all
    • 2 = somewhat troubled
    • 3 = moderately troubled
    • 4 = quite a bit troubled
    • 5 = very troubled
    • 6 = extremely troubled.

    The total or overall MiniRQLQ score is the mean of the 14 responses range (0-6).

    Measured: 6 Months

  4. Number of Participants With Device Related Adverse Events

    Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period

    Measured: Baseline and 3 months post study procedure

  5. rTNSS Scores at 3 Months

    The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:

    • 0 = absent symptoms (no sign/symptom is evident)
    • 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated)
    • 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable)
    • 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping).

    The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12

    A low score indicates lower symptoms, a higher score indicates more symptoms.

    Measured: 3 Months

  6. rTNSS Score at 6 Months

    The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:

    • 0 = absent symptoms (no sign/symptom is evident)
    • 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated)
    • 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable)
    • 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping).

    The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12

    A low score indicates lower symptoms, a higher score indicates more symptoms.

    Measured: 6 Months

  7. rTNSS Change From Baseline at 6 Months Post Procedure

    The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:

    • 0 = absent symptoms (no sign/symptom is evident)
    • 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated)
    • 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable)
    • 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping).

    The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12

    A low score indicates lower symptoms, a higher score indicates more symptoms.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2020
  2. Study start5 Oct 2020
  3. Primary completion30 Jun 2021
  4. Study completion20 Dec 2024

Resources

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
Model description
Active treatment for all subject enrolling prospectively
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04614324
Sponsor's protocol ID
CTP1056
Acronym
RELIEF
Status last verified
Oct 2026
First submitted
27 Oct 2020
Last updated
2 Nov 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No data collected will be shared with other researchers participating in the study

Publications

  • Lee JT, Abbas GM, Charous DD, Cuevas M, Goktas O, Loftus PA, Nachlas NE, Toskala EM, Watkins JP, Brehmer D. Two-Year Outcomes After Radiofrequency Neurolysis of Posterior Nasal Nerve in Chronic Rhinitis. Laryngoscope. 2024 May;134(5):2077-2084. doi: 10.1002/lary.31120. Epub 2023 Nov 2.

    PubMed 37916848
  • Lee JT, Abbas GM, Charous DD, Cuevas PDMM, Goktas PDMO, Loftus PA, Nachlas NE, Toskala EM, Watkins JP, Brehmer PDMD. Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis. Am J Rhinol Allergy. 2022 Nov;36(6):747-754. doi: 10.1177/19458924221109987. Epub 2022 Jul 11.

    PubMed 35818709
  • Kohlfaerber T, Pieper M, Munter M, Holzhausen C, Ahrens M, Idel C, Bruchhage KL, Leichtle A, Konig P, Huttmann G, Schulz-Hildebrandt H. Dynamic microscopic optical coherence tomography to visualize the morphological and functional micro-anatomy of the airways. Biomed Opt Express. 2022 May 5;13(6):3211-3223. doi: 10.1364/BOE.456104. eCollection 2022 Jun 1.

    PubMed 35781952
  • Lee JT, Abbas GM, Charous DD, Cuevas M, Goktas O, Loftus PA, Nachlas NE, Toskala EM, Watkins JP, Brehmer D. Three-Year Outcomes After Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Chronic Rhinitis. Am J Rhinol Allergy. 2025 Nov;39(6):398-409. doi: 10.1177/19458924251360889. Epub 2025 Aug 4.

    PubMed 40760831

Questions about this trial

What is this clinical trial studying?

A study testing RhinAer ARC Stylus in people with Chronic Rhinitis, run by Aerin Medical at 15 sites in 2 countries.

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 7 inclusion and 13 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, 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?

Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS) (time frame: Baseline and 3 months post study procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04614324, which also lists 4 linked publications.

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 2 Nov 2026.

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