Pulsed field ablation of the posterior nasal nerve for chronic rhinitis

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

This treatment uses a handheld device that delivers non-thermal pulsed field energy to the posterior nasal nerve to try to reduce symptoms in adults with chronic rhinitis who haven't had enough relief from nasal steroids.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Aventix Medical Inc. (Industry-sponsored)
• Locations: 3 sites (Colorado Springs, Colorado and 2 other locations)
• Trial ID: NCT06598319 on ClinicalTrials.gov

What this trial studies

This is a prospective, multi-center, single-arm, non-significant-risk study of the NOVOCLEAR™ Device used with the AVENTIX™ PFX System to treat chronic rhinitis. The device delivers non-thermal pulsed field energy to soft tissues in the nasal airway, including the posterior nasal nerve distribution. Adults 18–85 with symptoms for more than six months and rTNSS ≥6 who have insufficient response to nasal steroids will be enrolled and treated at participating ENT centers. Safety, tolerability, and symptom changes will be followed over scheduled visits after the procedure.

Who should consider this trial

Good fit: Adults aged 18–85 with chronic rhinitis for over six months, an rTNSS total score ≥6, moderate-to-severe rhinorrhea or congestion, and inadequate response to nasal steroid therapy are the intended candidates.

Not a fit: Patients with significant anatomic obstructions (severe septal deviation, nasal polyps, sinonasal tumor), septal perforation, prior PNN surgery, or major altered posterior nasal anatomy from prior sinus/nasal surgery are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the procedure could reduce nasal congestion and rhinorrhea and lessen the need for ongoing medication in people with chronic rhinitis.

How similar studies have performed: Prior work using radiofrequency or cryoablation of the posterior nasal nerve has shown symptom improvements, but non-thermal pulsed field treatment for this target is a newer and less-tested approach.

Eligibility criteria

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

Where this trial is running

Colorado Springs, Colorado and 2 other locations

• Colorado ENT and Allergy — Colorado Springs, Colorado, United States (Recruiting)
• Bay Area ENT — Ocean Springs, Mississippi, United States (Recruiting)
• Atkins Expert Sinus Care — San Antonio, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Raymond Weiss, MD — Bay Area ENT
• Study coordinator: ClinicalAdmin

Conditions Chronic Rhinitis; rhinitis, posterior nasal nerve