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

NCT04614324 | Completed Results FDA Device

• 1 other identifier: CTP1056
• Study Type: interventional
• Target: 129
• Locations: 2 countries
• Sites: 15

Brief Summary

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

Conditions

Chronic Rhinitis

Outcome Measures

Primary Outcomes (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

  Baseline and 3 months post study procedure

Secondary Outcomes (7)

• Participant Responder Percentage

  Baseline and 3 months post study procedure

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

  Baseline and 3 months post study procedure

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

  6 Months

• Number of Participants With Device Related Adverse Events

  Baseline and 3 months post study procedure

• rTNSS Scores at 3 Months

  3 Months

Study Arms (1)

RhinAer ARC Stylus Treatment

EXPERIMENTAL

The 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.

Device: RhinAer ARC Stylus

Interventions

RhinAer ARC Stylus DEVICE

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).

RhinAer ARC Stylus Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aerin Medical: lead

Study Sites (15)

Arizona Desert ENT Specialists

Goodyear, Arizona, 85395, United States

Location

Sacramento ENT

Roseville, California, 95661, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

ENT Associates of South Florida

Boca Raton, Florida, 33487, United States

Location

ENT and Allergy Associates of Florida

Port Saint Lucie, Florida, 34952, United States

Location

Florida ENT and Allergy

Tampa, Florida, 33619, United States

Location

Chicago Nasal and Sinus Center

Chicago, Illinois, 60602, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40220, United States

Location

Baton Rouge General / Sinus and Nasal Specialists of Louisiana

Baton Rouge, Louisiana, 70809, United States

Location

Piedmont ENT Associates

Winston-Salem, North Carolina, 27103, United States

Location

Fort Worth ENT

Fort Worth, Texas, 76109, United States

Location

ENT and Allergy Associates of Texas

McKinney, Texas, 75070, United States

Location

HNO-ZENTRUM am Kudamm

Berlin, Germany

Location

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Location

Facharzt für Hals- Nasen- und Ohrenkrankheiten Allergologie Plastische Operationen

Göttingen, Germany

Location

Related Publications (4)

• 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.

  PMID: 37916848 RESULT

• 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.

  PMID: 35818709 RESULT

• 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.

  PMID: 35781952 RESULT

• 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.

  PMID: 40760831 RESULT

Limitations and Caveats

Lack of a control arm and the limited follow-up to date It is possible that placebo effects may have contributed to the overall observed effect. Medication use was not limited by the protocol Future research is needed to determine cost-benefit analysis.

Results Point of Contact

• Title: Anais Laborde Sr. Director of Clinical Affairs
• Organization: Aerin Medical

alaborde@aerinmedical.com

650-518-9624

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active treatment for all subject enrolling prospectively

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 4, 2020
• Study Start: October 5, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 20, 2024
• Last Updated: August 28, 2025
• Results First Posted: August 21, 2024

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); DE (3)