Portable ultrasound-guided high-intensity focused ultrasound with functions for safe and rapid ablation: prospective clinical trial for uterine fibroids-short-term and long-term results

Objectives To investigate the efficacy and safety of a new portable ultrasound-guided high-intensity focused ultrasound system (USgHIFU) with advanced targeting and beam steering technology for the treatment of uterine fibroids. Methods Fifty-nine uterine fibroids from 36 participants (mean age, 44.9 +/- 4.1 years) were included from November 2013 to November 2015. All participants were treated with HIFU, with 3D electronic steering. MR imaging studies were performed before HIFU, immediately after HIFU, and 1 month and 3 (or 5) months after the HIFU treatment. The non-perfused volume ratio (NPVR), fibroid volume shrinkage (FVS), symptom improvement, quantified life quality assessment, and safety were analyzed. A long-term follow-up was conducted in July to December 2017 (mean, 32.2 months). Results The volume of the treated uterine fibroids ranged from 7.5 to 274.4 cm(3) (mean, 69.8 cm(3); SD, 64.3 cm(3)). The mean NPVR on the immediate post-HIFU MR imaging was 74.8 +/- 25.2%. The mean FVS was 17.3% at 1 month, 33.3% at 3 months, and 45.1% at 5 months after HIFU treatment. The mean treatment time was 44.6 +/- 28.2 min per fibroid and 72.9 +/- 31.4 min per participant. Uterine fibroid-related symptoms and quality of life showed statistically significant improvement after the HIFU treatment. No significant symptoms related to safety or complications occurred. In the long-term follow-up, 78.8% of those surveyed were satisfied with their HIFU treatment. Conclusion This clinical trial showed that a portable USgHIFU with advanced functions may safely and effectively treat uterine fibroids.