Chronic RhinitisRHINTRACNCT04533438

RhinAer Procedure for Treatment of Chronic Rhinitis Study

A study testing RhinAer Stylus in people with Chronic Rhinitis, run by Aerin Medical at 13 sites in United States.

Completed

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

Trial summary

The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of 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 Stylus
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 116 participants
Where: 13 sitesUnited States
Study dates: 31 Jul 2020to 30 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

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Piedmont ENT
Atlanta, Georgia, 30309
Rush University
Chicago, Illinois, 60612
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
Texas Healthcare
Fort Worth, Texas, 76104
Fredericksburg ENT
Fredericksburg, Texas, 78624
ENT Associates of Texas (ENTtex)
McKinney, Texas, 75070
Vanderbilt Asthma, Sinus & Allergy Program
Nashville, Tennessee, 37232
Madison ENT
New York, New York, 10016
Ogden Clinic
Ogden, Utah, 84403
ENT and Allergy Associates of Florida
Plantation, Florida, 33324
Sacramento ENT (DaVinci Research)
Roseville, California, 95661
University of South Florida
Tampa, Florida, 33612
Breathe Clear Institute
Torrance, California, 90503

Other trials in United States

About this study

Official title: The RhinAer Procedure for Treatment of CHronic RhInitis - A Prospective, MulticeNter Randomized ConTrolled TRial Comparing RhinAer to Sham Control (RHINTRAC)

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

Read the detailed description

The purpose of this study is to compare the RhinAer procedure to treat tissue in the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis with a sham procedure that duplicates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.

Conditions: Chronic Rhinitis
Being tested: RhinAer Stylus, Sham

What participants receive

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

RhinAer StylusDevice
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.
ShamDevice
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).

Study groups in NCT04533438
Study group	Role	What they receive
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 Receives: 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). Receives: Device: Sham

What is being measured

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

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
Measured: 3 months visit following the study procedure.

Secondary outcomes (3)

Reflective Total Nasal Symptom Score (rTNSS) Mean Change
The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity.
This study will measure the mean change in rTNSS from baseline to 3 months after the procedure.
Measured: Change from Baseline to 3 months following the study procedure.
Reflective Total Nasal Symptom Score (rTNSS) Mean Change
The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity.
Measured: Change from Baseline to 12 months following the study procedure.
Percentage of Participants With Treatment Related Events (Safety)
Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, severity, duration and outcome will be documented.
Measured: At or following the study procedure up to to 3 months.

Timeline

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

31 Jul 202030 Dec 2024

First posted31 Aug 2020
Study start31 Jul 2020
Primary completion9 Apr 2021
Study completion30 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic RhinitisStudies 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: Randomised
Intervention model: Crossover
Model description: 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.
Masking: Single blind
Who is masked: Participant
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04533438
Sponsor's protocol ID: CTP1004
Acronym: RHINTRAC
Status last verified: Apr 2025
First submitted: 21 Aug 2020
Last updated: 2 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 34527852
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.
PubMed 35714267
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.
PubMed 38266636
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.
PubMed 40183781

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The RhinAer Procedure for Treatment of CHronic RhInitis - A Prospective, MulticeNter Randomized ConTrolled TRial Comparing RhinAer to Sham Control (RHINTRAC)
ClinicalTrials.gov ID: NCT04533438
Acronym / sponsor ID: RHINTRAC / CTP1004
Conditions: Chronic Rhinitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Aerin MedicalIndustry (pharma, biotech, devices)
Study start: 31 Jul 2020 (actual)
Primary completion: 9 Apr 2021 (actual)
Study completion: 30 Dec 2024 (actual)
First posted: 31 Aug 2020 (actual)
Results: Posted 20 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
RhinAer Treatment	Active comparator	Device: RhinAer StylusThe 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
Control Treatment	Sham comparator	Device: ShamThe 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).

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (13 listed)

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.

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
RhinAer StylusThe 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.	Device	RhinAer Treatment
ShamThe 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	Control Treatment

Primary outcome

Reflective Total Nasal Symptom Score (rTNSS) Responder Rate
Time frame: 3 months visit following the study procedure.
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 secondary outcomes

Reflective Total Nasal Symptom Score (rTNSS) Mean Change
Time frame: Change from Baseline to 3 months following the study procedure.
Reflective Total Nasal Symptom Score (rTNSS) Mean Change
Time frame: Change from Baseline to 12 months following the study procedure.
Percentage of Participants With Treatment Related Events (Safety)
Time frame: At or following the study procedure up to to 3 months.

Results and safety

Results posted to the registry on 20 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RhinAer Treatment	77	77
Control Treatment	39	39

Primary outcome: Reflective Total Nasal Symptom Score (rTNSS) Responder Rate

Time frame: 3 months visit following the study procedure.. Count of participants. Unit: Participants

Measure	Active Treatment n = 77	Sham Control n = 39
Value	52	16

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RhinAer Treatment	0 of 77 (0%)	7 of 77 (9.1%)	0 of 77
Control Treatment	0 of 39 (0%)	1 of 39 (2.6%)	0 of 39

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 34527852Stolovitzky 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.
Results publication: PubMed 35714267Takashima 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.
Results publication: PubMed 38266636Takashima 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.
Results publication: PubMed 40183781Stolovitzky 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.
Individual participant dataSharing planned: No

Related trials for Chronic Rhinitis

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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.

Pablo Stolovitzky, MD principal investigator

ENT of Georgia North

Mas Takashima, MD principal investigator

The Sinus Center at Houston Methodist Hospital

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RhinAer Stylus in people with Chronic Rhinitis, run by Aerin Medical at 13 sites in United States.

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 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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. Some participants in this study may receive a placebo. 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 20 Dec 2022). 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?

Reflective Total Nasal Symptom Score (rTNSS) Responder Rate (time frame: 3 months visit following the 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 NCT04533438, 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 May 2025.