Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis

The NOVOCLEAR™ Device is a radiofrequency-based hand-held device intended to treat chronic rhinitis by delivering pulsed field energy to soft tissues in the nasal airway, including the posterior nasal nerve distribution. The NOVOCLEAR™ Device is used with the AVENTIX™ PFX System. The AVENTIX™ PFX System is a radiofrequency-based electrosurgical system designed to deliver non-thermal pulsed field energy to the targeted tissue.

This is a non-significant risk, prospective, multi-center, single arm study to evaluate the safety, effectiveness and tolerability of the NOVOCLEAR™ Device used with the AVENTIX™ PFX System.

Inclusion criteria

• The subject is 18 to 85 years of age.
• The subject has had symptoms of chronic rhinitis for greater than 6 months with insufficient response to nasal steroids.
• The subject has an rTNSS total score of ≥ 6.
• The subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion (rTNSS rating of 2 or 3 for rhinorrhea and 1, 2, or 3 for congestion)
• The subject is able and willing to provide written informed consent and comply with the protocol requirements.

Exclusion criteria

• The subject has clinically significant anatomic obstructions on either side that limit access to the posterior nose, including severe septal deviation, nasal polyps, and sinonasal tumor
• The subject has a septal perforation
• The subject has had prior sinus or nasal surgery on either side that significantly alters the anatomy of the posterior nose.
• The subject had had previous surgery of the PNN for chronic rhinitis.
• The subject has had prior head or neck irradiation
• The subject has an active or chronic nasal or sinus infection
• The subject has active coagulation disorder, or the patient is receiving anticoagulants
• The subject has a history of dry eye or dry nose symptoms
• Patient has rhinitis medicamentosa
• The subject has ocular allergic symptoms
• The subject has a history of nose bleeds
• The subject has electrically sensitive implants (e.g. cochlear implants, pacemakers, defibrillators)
• The subject is pregnant or lactating
• The subject is participating in another clinical research study
• The subject has an allergy or intolerance to anesthetic agent
• Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or pose an increased risk