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

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

Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of 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:

1. The subject is 18 to 85 years of age.
2. The subject has had symptoms of chronic rhinitis for greater than 6 months with insufficient response to nasal steroids.
3. The subject has an rTNSS total score of ≥ 6.
4. 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)
5. The subject is able and willing to provide written informed consent and comply with the protocol requirements.

Exclusion Criteria:

1. 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
2. The subject has a septal perforation
3. The subject has had prior sinus or nasal surgery on either side that significantly alters the anatomy of the posterior nose.
4. The subject had had previous surgery of the PNN for chronic rhinitis.
5. The subject has had prior head or neck irradiation
6. The subject has an active or chronic nasal or sinus infection
7. The subject has active coagulation disorder, or the patient is receiving anticoagulants
8. The subject has a history of dry eye or dry nose symptoms
9. Patient has rhinitis medicamentosa
10. The subject has ocular allergic symptoms
11. The subject has a history of nose bleeds
12. The subject has electrically sensitive implants (e.g. cochlear implants, pacemakers, defibrillators)
13. The subject is pregnant or lactating
14. The subject is participating in another clinical research study
15. The subject has an allergy or intolerance to anesthetic agent
16. Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or pose an increased risk