RhinAer Procedure for Treatment of Chronic Rhinitis Study

NCT04533438 | Completed Results FDA Device

• 1 other identifier: CTP1004
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.

Conditions

Chronic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Reflective Total Nasal Symptom Score (rTNSS) Responder Rate

  TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. 4 Symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) are reported with score of 0/absent; 1/mild; 2/moderate; 3/severe. The total score is the sum of the 4 nasal symptom scores with a maximum TNSS of 12 indicating the most severe symptoms. Treatment Responder based on rTNSS improvement Individual participant success (responder) is defined as at least 30% improvement (decrease) in the rTNSS from baseline. For this protocol patients had to meet inclusion criteria of rTNSS rating of 2 or 3 for Rhinorrhea; rTNSS rating of 1, 2 or 3 for Congestion; and total rTNSS score \>/= 6 at baseline

  3 months visit following the study procedure.

Secondary Outcomes (3)

• Reflective Total Nasal Symptom Score (rTNSS) Mean Change

  Change from Baseline to 3 months following the study procedure.

• Reflective Total Nasal Symptom Score (rTNSS) Mean Change

  Change from Baseline to 12 months following the study procedure.

• Percentage of Participants With Treatment Related Events (Safety)

  At or following the study procedure up to to 3 months.

Other Outcomes (1)

• Nasal Status Assessment

  Baseline, 1 month, 3 months and 6 months following the study procedure

Study Arms (2)

RhinAer Treatment

ACTIVE COMPARATOR

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 the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session. Each nostril will be treated at 1, 2, 3, 4 or 5 nonoverlapping positions depending on the size of the target treatment area. Treatment settings to be used are temperature 60 °C, power 4 watts, treatment time 12 seconds, and cooling time 0 seconds

Device: RhinAer Stylus

Control Treatment

SHAM COMPARATOR

The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Device: Sham

Interventions

RhinAer Stylus DEVICE

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 the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session.

RhinAer Treatment

Sham DEVICE

The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Control 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 (13)

Sacramento ENT (DaVinci Research)

Roseville, California, 95661, United States

Location

Breathe Clear Institute

Torrance, California, 90503, United States

Location

ENT and Allergy Associates of Florida

Plantation, Florida, 33324, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Piedmont ENT

Atlanta, Georgia, 30309, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Madison ENT

New York, New York, 10016, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

Vanderbilt Asthma, Sinus & Allergy Program

Nashville, Tennessee, 37232, United States

Location

Texas Healthcare

Fort Worth, Texas, 76104, United States

Location

Fredericksburg ENT

Fredericksburg, Texas, 78624, United States

Location

ENT Associates of Texas (ENTtex)

McKinney, Texas, 75070, United States

Location

Ogden Clinic

Ogden, Utah, 84403, United States

Location

Related Publications (4)

• Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD, Takashima M. Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial. OTO Open. 2021 Sep 10;5(3):2473974X211041124. doi: 10.1177/2473974X211041124. eCollection 2021 Jul-Sep.

  PMID: 34527852 RESULT

• Takashima M, Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD. Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. 2023 Feb;13(2):107-115. doi: 10.1002/alr.23047. Epub 2022 Jul 5.

  PMID: 35714267 RESULT

• Takashima M, Stolovitzky JP, Ow RA, Silvers SL, McDuffie CM, Dean M, Sedaghat AR, Tajudeen BA. Temperature-controlled radiofrequency ablation for the treatment of chronic rhinitis: Two-year outcomes from a prospective multicenter trial. Int Forum Allergy Rhinol. 2024 Jul;14(7):1182-1194. doi: 10.1002/alr.23315. Epub 2024 Jan 24.

  PMID: 38266636 RESULT

• Stolovitzky JP, Ow RA, Silvers SL, Tajudeen BA, McDuffie CM, Dean M, Sedaghat AR, Phillips K, Takashima M. 3-Year Outcomes of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve in Patients With Chronic Rhinitis. Int Forum Allergy Rhinol. 2025 Sep;15(9):915-925. doi: 10.1002/alr.23577. Epub 2025 Apr 4.

  PMID: 40183781 RESULT

Limitations and Caveats

Patients with a predisposition to poor wound healing were excluded from this trial, and therefore, the results may not be applicable to this patient population. Investigators were not blinded. The rTNSS used in endpoint evaluation was reported by the blinded patient, mitigating the risk of bias. Pain VAS was completed by the blinded patients. Allergy testing not required and relative efficacy by rhinitis subtype could not be compared. Medication use was not controlled

Results Point of Contact

• Title: Sr. Manager of Clinical Operations
• Organization: Aerin Medical

tdang@aerinmedical.com

312-888-0441

Study Officials

• Pablo Stolovitzky, MD

  ENT of Georgia North

  PRINCIPAL INVESTIGATOR

• Mas Takashima, MD

  The Sinus Center at Houston Methodist Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to the study arm they are assigned to.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 site-stratified randomization will be used to allocate participants to either the RhinAer procedure or treatment with the sham (control) procedure. Crossover within 30 days after 3- or 6-month follow-up visit.

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 31, 2020
• Study Start: July 31, 2020
• Primary Completion: April 9, 2021
• Study Completion: December 30, 2024
• Last Updated: May 2, 2025
• Results First Posted: December 20, 2022

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)