RhinAer Procedure for Treatment of Chronic Rhinitis Study (RHINTRAC)

Aerin Medical

Status: Active, not recruiting

Conditions: Chronic Rhinitis

Treatments: Device: Sham; Device: RhinAer Stylus

Study type: Interventional

Funder types: Industry

Identifiers

NCT04533438

CTP1004

Details and patient eligibility

About

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

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18 to 85 years (inclusively).
2. Willing and able to provide informed consent.
3. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
4. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure.
5. Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea).
6. Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion).
7. rTNSS ≥ 6.

Exclusion criteria

1. Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
2. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.
3. Active nasal or sinus infection.
4. History of significant dry eye.
5. 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.
6. Have rhinitis symptoms only on a seasonal basis due to allergies.
7. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
8. Known or suspected to be pregnant or is lactating.
9. Participating in another clinical research study.
10. Has any condition that predisposes to excessive bleeding.
11. Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure.
12. Has previous procedure or surgery for chronic rhinitis.
13. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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116 participants in 2 patient groups

RhinAer Treatment

Active Comparator group

Description:

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

Treatment:

Device: RhinAer Stylus

Control Treatment

Sham Comparator group

Description:

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).

Treatment:

Device: Sham