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

  • Jae Young LeeEmail author
  • Hyun Hoon Chung
  • Soo Yeon Kang
  • Eun-Joo Park
  • Dong Hyuk Park
  • Keonho Son
  • Joon Koo Han



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.

Key Points

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.


Uterine 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) ( was involved in the whole process of this study from research planning to Korean FDA licensing of this device.

Funding information

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.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional Review Board approval was obtained.


• Prospective study

• Observational study

• Performed at one institution

Supplementary material

330_2019_6468_MOESM1_ESM.docx (9.5 mb)
ESM 1 (DOCX 9693 kb)


  1. 1.
    Choi JW, Lee JY, Hwang EJ et al (2014) Portable high-intensity focused ultrasound system with 3D electronic steering, real-time cavitation monitoring, and 3D image reconstruction algorithms: a preclinical study in pigs. Ultrasonography 33:191–199CrossRefGoogle Scholar
  2. 2.
    Kovatcheva RD, Vlahov JD, Stoinov JI, Zaletel K (2015) Benign solid thyroid nodules: US-guided high-intensity focused ultrasound ablation-initial clinical outcomes. Radiology 276:597–605CrossRefGoogle Scholar
  3. 3.
    Kovatcheva R, Zaletel K, Vlahov J, Stoinov J (2017) Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma. J Ther Ultrasound 5:1CrossRefGoogle Scholar
  4. 4.
    Munro MG, Critchley HO, Broder MS, Fraser IS (2011) FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet 113:3–13CrossRefGoogle Scholar
  5. 5.
    Wang W, Wang Y, Wang T, Wang J, Wang L, Tang J (2012) Safety and efficacy of US-guided high-intensity focused ultrasound for treatment of submucosal fibroids. Eur Radiol 22:2553–2558CrossRefGoogle Scholar
  6. 6.
    Rabinovici J, Inbar Y, Revel A et al (2007) Clinical improvement and shrinkage of uterine fibroids after thermal ablation by magnetic resonance-guided focused ultrasound surgery. Ultrasound Obstet Gynecol 30:771–777CrossRefGoogle Scholar
  7. 7.
    Stewart EA, Rabinovici J, Tempany CM et al (2006) Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids. Fertil Steril 85:22–29CrossRefGoogle Scholar
  8. 8.
    Gizzo S, Saccardi C, Patrelli TS et al (2014) Magnetic resonance-guided focused ultrasound myomectomy: safety, efficacy, subsequent fertility and quality-of-life improvements, a systematic review. Reprod Sci 21:465–476CrossRefGoogle Scholar
  9. 9.
    Chung MS, Jung SC, Kim SO et al (2017) Intracranial artery steno-occlusion: diagnosis by using two-dimensional spatially selective radiofrequency excitation pulse MR imaging. Radiology 284:834–843CrossRefGoogle Scholar
  10. 10.
    Wang X, Qin J, Chen J, Wang L, Chen W, Tang L (2013) The effect of high-intensity focused ultrasound treatment on immune function in patients with uterine fibroids. Int J Hyperthermia 29:225–233CrossRefGoogle Scholar
  11. 11.
    Meng X, He G, Zhang J et al (2010) A comparative study of fibroid ablation rates using radio frequency or high-intensity focused ultrasound. Cardiovasc Intervent Radiol 33:794–799CrossRefGoogle Scholar
  12. 12.
    Leung JH, Yu SC, Cheung EC et al (2014) Safety and efficacy of sonographically guided high-intensity focused ultrasound for symptomatic uterine fibroids: preliminary study of a modified protocol. J Ultrasound Med 33:1811–1818CrossRefGoogle Scholar
  13. 13.
    Ren XL, Zhou XD, Zhang J et al (2007) Extracorporeal ablation of uterine fibroids with high-intensity focused ultrasound: imaging and histopathologic evaluation. J Ultrasound Med 26:201–212CrossRefGoogle Scholar
  14. 14.
    Wang F, Tang L, Wang L et al (2014) Ultrasound-guided high-intensity focused ultrasound vs laparoscopic myomectomy for symptomatic uterine myomas. J Minim Invasive Gynecol 21:279–284CrossRefGoogle Scholar
  15. 15.
    Wang X, Qin J, Wang L, Chen J, Chen W, Tang L (2013) Effect of high-intensity focused ultrasound on sexual function in the treatment of uterine fibroids: comparison to conventional myomectomy. Arch Gynecol Obstet 288:851–858CrossRefGoogle Scholar
  16. 16.
    Cho JY, Kim SH, Kim SY, Moon SK, Li J (2013) Efficacy and safety of daily repeated sonographically guided high-intensity focused ultrasound treatment of uterine fibroids: preliminary study. J Ultrasound Med 32:397–406CrossRefGoogle Scholar
  17. 17.
    Mindjuk I, Trumm CG, Herzog P, Stahl R, Matzko M (2015) MRI predictors of clinical success in MR-guided focused ultrasound (MRgFUS) treatments of uterine fibroids: results from a single centre. Eur Radiol 25:1317–1328CrossRefGoogle Scholar
  18. 18.
    Park MJ, Kim YS, Keserci B, Rhim H, Lim HK (2013) Volumetric MR-guided high-intensity focused ultrasound ablation of uterine fibroids: treatment speed and factors influencing speed. Eur Radiol 23:943–950CrossRefGoogle Scholar
  19. 19.
    Kim YS, Lee JW, Choi CH et al (2016) Uterine fibroids: correlation of T2 signal intensity with semiquantitative perfusion MR parameters in patients screened for MR-guided high-intensity focused ultrasound ablation. Radiology 278:925–935CrossRefGoogle Scholar
  20. 20.
    Funaki K, Fukunishi H, Funaki T, Sawada K, Kaji Y, Maruo T (2007) Magnetic resonance-guided focused ultrasound surgery for uterine fibroids: relationship between the therapeutic effects and signal intensity of preexisting T2-weighted magnetic resonance images. Am J Obstet Gynecol 196(184):e181–e186Google Scholar
  21. 21.
    Park H, Yoon SW, Sokolov A (2015) Scaled signal intensity of uterine fibroids based on T2-weighted MR images: a potential objective method to determine the suitability for magnetic resonance-guided focused ultrasound surgery of uterine fibroids. Eur Radiol 25:3455–3458CrossRefGoogle Scholar
  22. 22.
    Ueda H, Togashi K, Konishi I et al (1999) Unusual appearances of uterine leiomyomas: MR imaging findings and their histopathologic backgrounds. Radiographics 19 Spec No:S131–S145CrossRefGoogle Scholar
  23. 23.
    Yoon SW, Lee C, Cha SH et al (2008) Patient selection guidelines in MR-guided focused ultrasound surgery of uterine fibroids: a pictorial guide to relevant findings in screening pelvic MRI. Eur Radiol 18:2997–3006CrossRefGoogle Scholar
  24. 24.
    Swe TT, Onitsuka H, Kawamoto K, Ueyama T, Tsuruchi N, Masuda K (1992) Uterine leiomyoma: correlation between signal intensity on magnetic resonance imaging and pathologic characteristics. Radiat Med 10:235–242PubMedGoogle Scholar
  25. 25.
    Park MJ, Kim YS, Rhim H, Lim HK (2014) Safety and therapeutic efficacy of complete or near-complete ablation of symptomatic uterine fibroid tumors by MR imaging-guided high-intensity focused US therapy. J Vasc Interv Radiol 25:231–239CrossRefGoogle Scholar
  26. 26.
    Gorny KR, Woodrum DA, Brown DL et al (2011) Magnetic resonance-guided focused ultrasound of uterine leiomyomas: review of a 12-month outcome of 130 clinical patients. J Vasc Interv Radiol 22:857–864CrossRefGoogle Scholar
  27. 27.
    Kim HS, Baik JH, Pham LD, Jacobs MA (2011) MR-guided high-intensity focused ultrasound treatment for symptomatic uterine leiomyomata: long-term outcomes. Acad Radiol 18:970–976CrossRefGoogle Scholar

Copyright information

© European Society of Radiology 2019

Authors and Affiliations

  1. 1.Department of Radiology and the Institute of Radiation MedicineSeoul National University HospitalSeoulRepublic of Korea
  2. 2.Department of RadiologySeoul National University College of MedicineSeoulRepublic of Korea
  3. 3.Department of Obstetrics & GynecologySeoul National University HospitalSeoulRepublic of Korea
  4. 4.Therapeutic Ultrasound DivisionAlpinion Medical Systems Co.SeoulRepublic of Korea

Personalised recommendations