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

Recruiting now · Not applicable

Conditions studied: Chronic Rhinitis

In brief

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

Key facts

Study ID

NCT06598319

Run by

Aventix Medical Inc.

People needed

30

Starts

2024-11-15

Expected to finish

2026-12-01

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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