Evaluation of Pulsed Field Ablation of the Posterior Nasal Nerve for Chronic Rhinitis
ConditionChronic Rhinitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAventix Medical Inc.
About this trial
Evaluation of safety, effectiveness and tolerability of the Aventix Medical Device used for the treatment of chronic rhinitis
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- NOVOCLEAR™ Device
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov