Safety and Efficacy of a Novel Radiofrequency Device for Submucosal Turbinate Reduction - A Prospective, Open-Label Pilot Trial.

OBJECTIVE:Inferior turbinate (IT) hypertrophy is a major cause of nasal obstruction. Although surgical intervention is effective, it can be associated with morbidity and prolonged recovery. This study evaluated the safety, efficacy, and tolerability of a novel submucosal fractional radiofrequency (FRF) treatment. METHODS:A prospective, single-arm, open-label study was conducted from March to November 2024. Patients with nasal obstruction caused by IT hypertrophy unresponsive to at least 1 month of medical treatment were included in the study. The procedure was performed endoscopically under topical anesthesia using FRF. Outcomes were assessed using the Nasal Obstruction Symptom Evaluation (NOSE) scale, Visual Analog Scale (VAS), and endoscopic turbinate grading at baseline, 1 month, and 3 months after the procedure. The safety outcomes included pain scale, adverse events, and complications. RESULTS:A total of 22 patients completed the protocol. The NOSE score improved from 71.2 to 30.0 at 1 month (P < .001). Sustained NOSE score improvement was observed at 3 months (37.1, P < .001). The VAS scores for nasal obstruction decreased from 7.4 to 3.2 at 1 month and 3.9 at 3 months (P < .0001). Endoscopic grading of turbinate size demonstrated a reduction at both follow-up points (P < .05). The average VAS score for pain was 3.4, indicating good tolerability. No bleeding, synechiae, or other adverse events were reported. Crusting appeared in 50% of patients at 1 month, resolving in all but 1 patient by 3 months. A significant correlation was observed between the pulse count and symptom improvement (P = .02). CONCLUSION:Submucosal FRF treatment leads to significant and sustained improvement in nasal obstruction with minimal pain and no major adverse events. These results support the safety, efficacy, and tolerability of the procedure for IT hypertrophy in an outpatient setting. Larger cohorts and long-term follow-up studies are warranted to refine the treatment and further validate these findings. LEVEL OF EVIDENCE:3.