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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)

Must not have

Has any condition that predisposes to excessive bleeding

History of significant dry eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 months and 6 months following the study procedure

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience mild to severe nasal congestion.

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I have moderate to severe runny nose symptoms.

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I have moderate to severe runny nose symptoms.

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I am between 18 and 85 years old.

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I experience mild to severe nasal congestion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that causes me to bleed easily.

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I have a history of severe dry eye.

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I am on blood thinners or high-dose aspirin that I can't stop before a procedure.

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I have had surgery for long-term nasal inflammation.

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I currently have a nasal or sinus infection.

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I have had chronic nosebleeds, severe nosebleeds in the last 3 months, medication-induced nasal congestion, or radiation therapy to my head or neck.

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My nose's structure changed due to past surgery or injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 months and 6 months following the study procedure

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reflective Total Nasal Symptom Score (rTNSS) Responder Rate

Secondary study objectives

Percentage of Participants With Treatment Related Events (Safety)

Reflective Total Nasal Symptom Score (rTNSS) Mean Change

Other study objectives

Nasal Status Assessment

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).

0 / 12Eligibility criteria met