← Back to Search

Procedure

RhinAer Stylus for Chronic Rhinitis (RHINTRAC Trial)

N/A
Waitlist Available
Led By Mas Takashima, MD
Research Sponsored by Aerin Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion)
Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months and 6 months following the study procedure
Awards & highlights

RHINTRAC Trial Summary

This trial compares the RhinAer procedure, which uses RF energy, to a sham procedure for the treatment of chronic rhinitis.

Who is the study for?
Adults aged 18-85 with chronic rhinitis symptoms for at least 6 months, who have moderate to severe runny nose and mild to severe nasal congestion. Participants must be willing to undergo an office-based procedure and follow the study protocol. Excluded are those in other studies, with nasal infections, significant dry eye history, recent nose bleeds, prior surgeries for chronic rhinitis or conditions causing excessive bleeding.Check my eligibility
What is being tested?
The trial is testing the RhinAer procedure that uses radiofrequency energy against a sham (fake) procedure to see which is better for treating chronic rhinitis. The real and sham procedures will be compared in participants randomly assigned to each group.See study design
What are the potential side effects?
Potential side effects of the RhinAer procedure may include discomfort at the treatment site, risk of infection from the procedure itself, possible bleeding due to RF energy application, and temporary worsening of respiratory symptoms.

RHINTRAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience mild to severe nasal congestion.
Select...
I have moderate to severe runny nose symptoms.
Select...
I have moderate to severe runny nose symptoms.
Select...
I have had chronic rhinitis for over 6 months and am open to an office procedure.
Select...
I am between 18 and 85 years old.
Select...
I experience mild to severe nasal congestion.

RHINTRAC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months and 6 months following the study procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months and 6 months following the study procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reflective Total Nasal Symptom Score (rTNSS) Responder Rate
Secondary outcome measures
Percentage of Participants With Treatment Related Events (Safety)
Reflective Total Nasal Symptom Score (rTNSS) Mean Change
Other outcome measures
Nasal Status Assessment

RHINTRAC Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: RhinAer TreatmentActive Control1 Intervention
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
Group II: Control TreatmentPlacebo Group1 Intervention
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).

Find a Location

Who is running the clinical trial?

Aerin MedicalLead Sponsor
11 Previous Clinical Trials
806 Total Patients Enrolled
3 Trials studying Chronic Rhinitis
235 Patients Enrolled for Chronic Rhinitis
Mas Takashima, MDPrincipal InvestigatorThe Sinus Center at Houston Methodist Hospital
1 Previous Clinical Trials
150 Total Patients Enrolled
Pablo Stolovitzky, MDPrincipal InvestigatorENT of Georgia North
1 Previous Clinical Trials
137 Total Patients Enrolled

Media Library

RhinAer Procedure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04533438 — N/A
Chronic Rhinitis Research Study Groups: RhinAer Treatment, Control Treatment
Chronic Rhinitis Clinical Trial 2023: RhinAer Procedure Highlights & Side Effects. Trial Name: NCT04533438 — N/A
RhinAer Procedure (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04533438 — N/A
Chronic Rhinitis Patient Testimony for trial: Trial Name: NCT04533438 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial currently available to prospective participants?

"According to clinicaltrials.gov, this trial has ceased patient recruitment as of July 27th 2022 - its last date of editing. Despite the lack of available slots in this study, there are a number of other trials that have open positions at present time."

Answered by AI

Could I qualify to join this research study?

"This clinical trial is accepting 120 voluntary participants between 18 and 85 years of age who experience signs of rhinitis. To be eligible for inclusion, the patient must willingly comply with any instructions specified in the study protocol as well as have nasal congestion ranging from mild to severe (rTNSS rating 1-3) and an overall rTNSS score ≥ 6."

Answered by AI

Does this study include individuals aged 50 and above?

"This clinical trial has an upper age limit of 85 years and a lower one set at the legal age of consent."

Answered by AI

How many sites within the city are offering this research experiment?

"This trial is being conducted across 20 locations, including Sacramento ENT (DaVinci Research) in Roseville and ENT of Georgia in Atlanta. Additionally, the Breathe Clear Institute in Torrance has also been enlisted as a clinical site for this study."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
What site did they apply to?
Breathe Clear Institute

Why did patients apply to this trial?

I’ve suffered rhinitis my whole life. Hoping this might help. I have had severe chronic allergy non rhinotis for years with little help and always on multiple medications.
PatientReceived 2+ prior treatments
~25 spots leftby Mar 2025