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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
Interventional
  • 1 Downloads

Abstract

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 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.

Conclusion

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.

Keywords

Uterine fibroid Leiomyoma, uterine High-intensity focused ultrasound ablation Treatment efficacy Ultrasonography, interventional 

Abbreviations

FVS

Fibroid volume shrinkage

HIFU

High-intensity focused ultrasound

MRgHIFU

MR-guided high-intensity focused ultrasound

NPVR

Non-perfused volume ratio

SF36-v2

36-Item Short-Form Health Survey, Version 2

SSS

Symptom severity score

UFS-QOL

The Uterine Fibroid Symptom and Quality of Life Questionnaire

USgHIFU

Ultrasound-guided high-intensity focused ultrasound

VAS

Visual analog scale

Notes

Acknowledgments

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.

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.

Guarantor

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.

Methodology

• Prospective study

• Observational study

• Performed at one institution

Supplementary material

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

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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

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