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
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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.
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).
The volume of the treated uterine fibroids ranged from 7.5 to 274.4 cm3 (mean, 69.8 cm3; SD, 64.3 cm3). 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.
This clinical trial showed that a portable USgHIFU with advanced functions may safely and effectively treat uterine fibroids.
• A portable compact ultrasound-guided high-intensity focused ultrasound (HIFU) can effectively and safely treat uterine fibroids.
• Advanced functions, such as portability, targeted forecasting, electronic beam steering, and interleaved scanning, might be helpful in enhancing the clinical applicability of ultrasound-guided high-intensity focused ultrasound.
• In the long-term follow-up of more than 2 years, approximately 80% of those surveyed were satisfied with their HIFU treatment.
KeywordsUterine fibroid Leiomyoma, uterine High-intensity focused ultrasound ablation Treatment efficacy Ultrasonography, interventional
Fibroid volume shrinkage
High-intensity focused ultrasound
MR-guided high-intensity focused ultrasound
Non-perfused volume ratio
36-Item Short-Form Health Survey, Version 2
Symptom severity score
The Uterine Fibroid Symptom and Quality of Life Questionnaire
Ultrasound-guided high-intensity focused ultrasound
Visual analog scale
Synex (Contract Research Organization, Seoul, Korea) (http://www.synex.co.kr) was involved in the whole process of this study from research planning to Korean FDA licensing of this device.
This work was supported by the R&D program of MOTIE (Ministry of Trade, Industry and Energy)/KEIT (Korean Evaluation Institute of Industrial Technology) (10043474, Development of an Ultrasound Guided HIFU Treatment System).
Compliance with ethical standards
This study adhered to the ethical standards of the Helsinki Declaration.
The scientific guarantor of this publication is Joon Koo Han, M.D., who is the immediate past-chief of our department.
Conflict of interest
The HIFU system for this study was provided by Alpinion Medical Systems (Seoul, Korea). However, the data of this study was completely controlled by the MD authors and regularly checked by the CRO, which were unbiased by the industry. Keonho Son, one author of this manuscript is working as a managing director for Alpinion Medical System.
Statistics and biometry
Synex (CRO, Seoul, Korea) kindly provided statistical advice (sample volume decision) for this manuscript. Other than that, no complex statistical methods were necessary for this paper.
Written informed consent was obtained from all subjects (patients) in this study.
Institutional Review Board approval was obtained.
• Prospective study
• Observational study
• Performed at one institution
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