Impedance-Controlled Multipoint Radiofrequency Ablation for Chronic Rhinitis: A Randomized Controlled Trial.

Area of Science:

• Otolaryngology
• Medical Devices
• Clinical Trials

Background:

• Chronic rhinitis significantly impacts patient quality of life.
• Current treatments for chronic rhinitis have limitations.
• Posterior nasal nerve ablation is a potential therapeutic option.

Purpose of the Study:

• To evaluate the efficacy of posterior nasal nerve ablation using the NEUROMARK System.
• To compare the NEUROMARK System treatment to a sham control for chronic rhinitis.
• To demonstrate the superiority of active treatment over sham control.

Main Methods:

• A prospective, multicenter, single-blinded, superiority randomized controlled trial (RCT).
• 132 participants randomized 2:1 to NEUROMARK System (n=88) or sham control (n=44).
• Primary endpoint: reflective Total Nasal Symptom Score (rTNSS) responder rate at 90 days. Secondary outcomes included NOSE, mini-RQLQ, and PHQ-9 scores.

Main Results:

• The NEUROMARK System active treatment arm showed a significantly higher rTNSS responder rate (73.3%) compared to sham (35.0%; p < 0.001).
• Significant improvements were observed in the active treatment arm for rTNSS, postnasal drip, cough, NOSE score, mini-RQLQ, and PHQ-9 compared to sham.
• Higher responder rates for NOSE and mini-RQLQ were achieved with the NEUROMARK System treatment.

Conclusions:

• Posterior nasal nerve ablation with the NEUROMARK System is a superior treatment for chronic rhinitis.
• The NEUROMARK System offers a significant benefit for patients suffering from chronic rhinitis symptoms.
• The study met its primary endpoint, confirming the efficacy of the NEUROMARK System.