Study of NOVOCLEAR Device Using Pulsed Field Ablation to Treat Chronic Rhinitis in Adults

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and tolerability of the NOVOCLEAR174 Device used with the AVENTIX174 PFX System for treating chronic rhinitis. This condition involves persistent nasal symptoms, and the study aims to understand how this radiofrequency-based pulsed field energy device affects the soft tissues in the nasal airway, including the posterior nasal nerve region. The study is a non-significant risk, prospective, multi-center, single arm trial supported by Aventix Medical Inc. The treatment involves applying pulsed field energy through the NOVOCLEAR174 Device to the nasal tissues, targeting the posterior nasal nerve area. This device works with the AVENTIX174 PFX System, which delivers non-thermal pulsed field energy. All participants receive this intervention during the study period there is no comparison group. Participants will be involved for at least 90 days, with assessments at 7, 14, 30, 90 days, 6 months, and 1 year after treatment. Researchers will measure changes in nasal symptoms using the Reflective Total Nasal Symptom Score rTNSS, procedure tolerability, and participant satisfaction. Safety is monitored through the occurrence of serious device or procedure-related adverse events. The study includes written consent and protocol compliance, with ongoing follow-up for up to one year.

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