RhinAer Stylus for Chronic Rhinitis

(RHINTRAC Trial)

Recruiting at 19 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aerin Medical

Must not be taking: Anticoagulants, Aspirin

Disqualifiers: Anatomic obstructions, Active infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

116 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Pablo Stolovitzky, MD

Principal Investigator

ENT of Georgia North

Mas Takashima, MD

Principal Investigator

The Sinus Center at Houston Methodist Hospital

Eligibility Criteria

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.

Inclusion Criteria

Willing and able to provide informed consent.

Your nasal symptoms score is 6 or higher.

I experience mild to severe nasal congestion.

Exclusion Criteria

I have a condition that causes me to bleed easily.

I have a history of severe dry eye.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the RhinAer procedure or a sham procedure in a single session to treat chronic rhinitis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of nasal symptoms and adverse events

12 months

Visits at 1 month, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• RhinAer Procedure
• Sham Procedure

Trial Overview 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.

Participant Groups

Group I: RhinAer Treatment Active Control 1 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 Treatment Placebo Group 1 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).

Who Is Running the Clinical Trial?

Aerin Medical

Lead Sponsor

Trials

13

Recruited

930+