Clinical efficacy study of a spherical nasal vestibular stent

To design and validate a spherical nasal vestibular stent based on vestibular structural changes for treating nasal obstruction.

This study enrolled 99 patients with nasal obstruction and confirmed positive findings on anterior rhinoscopy. Pre- and post-dilation sinonasal computed tomography (CT) scans were obtained until symptoms nearly resolved. Three-dimensional (3D) reconstruction was utilized to evaluate anatomical changes, and Spearman correlation analysis was performed to assess the relationship between these changes and visual analog scale (VAS) scores for nasal obstruction. Based on 3D reconstructed models and computational fluid dynamics (CFD) parameter evaluations, a nitinol mesh stent customized to the anatomical characteristics of the nasal vestibule was designed. A single-arm clinical trial in 31 patients was subsequently evaluated the stent using NOSE scores, acoustic rhinometry, and rhinomanometry before and after placement. Adverse events were systematically recorded.

3D reconstruction showed that changes in nasal vestibule volume before and after dilation correlated with patients' VAS scores for nasal obstruction. In the clinical trial, the spherical nasal vestibular stent-designed using nasal vestibule volume data-significantly reduced nasal resistance (p < 0.05), increased nasal volume and valve area (p < 0.001), and lowered NOSE scores (p < 0.001). Most patients tolerated the stent well; side effects like dryness and pain were mild.

Based on 3D models from dilated nasal vestibules, this study designed a spherical stent that effectively relieves nasal obstruction with minimal risk, positioning it as a promising non-surgical intervention for clinical application.