Table A1:
Characteristics of Reports on MRgHIFU Treatment of Uterine Fibroids
| Country, Device | Author, Year | Hospital(s) Source | Report Type | Recruitment Period | Study Size (Age) | Study Objective |
|---|---|---|---|---|---|---|
| Australia | ||||||
| ExAblate 2000 (InSightec Ltd., Haifa, Israel) 1.5T MR (Signa; GE Healthcare, Milwaukee, US) | Dobrotwir A and Pun E, 2012 (94) | The Royal Women's Hospital, Melbourne, Victoria | Single site prospective longitudinal cohort study | May 2009 to April 2011 | 100 women (mean age 42 ± 7 years) | Treatment effectiveness; outcomes, 24-months follow-up |
| Brazil | ||||||
| ExAblate 2000 (InSightec Ltd., Haifa, Israel) 1.5T MR (Signa; GE Healthcare, Milwaukee, US) | De Melo F et al, 2009 (138) | LABS-D'OR Hospital Network, Rio de Janeiro | Case report | NR | 41-year-old woman | Technical report; treatment success with ablation focused only at tumour periphery at 12-month follow-up |
| China | ||||||
| HIFU 9000 (Shanghai Aishen Technology, Shanghai, China) and Valleylab Cool-Tip (Valleylab/Tyco Healthcare Group, Boulder, CO, US) | Meng X et al, 2010 (52) | Xijing Hospital, Shaanxi | RCT, USgHIFU versus radiofrequency ablation | March 2009 to August 2009 | 100 women: USgHIFU 50 women (mean age 35.6 ± 6.0 years; range, 26–47)) vs. RF 50 women (mean age 39.2 ± 5.7 years; range, 24–48) | Comparative study; RCT to compare the efficacy of USgHIFU with radiofrequency ablation |
| JC-HIFU (Chongqing Haifu Technology Co. Ltd, Chongqing, China) | Qin J et al, 2012 (54) | Chongquing University Medical Center, Chongquing | Case series nested within a cohort study | October 1, 2006, to October 1, 2009 | USgHIFU 435 women: 24 women (mean age 34.5 ± 4.5 years; range, 25–42) achieving unplanned pregnancy within 1 year of treatment | Reproductive report to review outcomes of unplanned pregnancies occurring in a cohort of women undergoing USgHIFU |
| JC-HIFU (Chongqing Haifu Technology Co. Ltd., Chongqing, China) | Wang X et al, 2013 (59) | Chongquing University Medical Center, Chongquing | RCT, USgHIFU versus abdominal myomectomy | NR | 120 women: USgHIFU 60 women (mean age 39.9 ± 5.2 years) and myomectomy 60 women (mean age 38.6 ± 4.4 years) | Comparative study; RCT to evaluate the effect of USgHIFU compared to myomectomy on immune function |
| JC-HIFU (Chongqing Haifu Technology Co. Ltd., Chongqing, China) | Wang X et al, 2013 (58) | Chongquing University Medical Center, Chongquing | RCT, USgHIFU versus abdominal myomectomy | NR | 110 premenopausal women: HIFU 55 women (mean age 39.2 ± 5.2 years) vs. myomectomy 55 women (mean age 38.1 ± 4.6 years) | Comparative study; RCT to evaluate the effect of USgHIFU compared to myomectomy on sexual function |
| JC-HIFU (Chongqing Haifu Technology Co. Ltd., Chongqing, China) | Wang F et al, 2014 (56) | Chongquing University Medical Center, Chongquing | Comparative prospective longitudinal cohort study, USgHIFU versus laparoscopic myomectomy | January 2010 to December 2011 | 130 premenopausal women: HIFU 89 women (mean age 37.9 ± 5.5 years) vs. myomectomy 41 women (mean age 38.4 ± 5.0 years) | Comparative cohort study to evaluate the effect of USgHIFU compared to laparoscopic myomectomy on complications, symptom relief, hospital stay, recovery, treatment satisfaction, QOL, and 12-month outcomes |
| Germany | ||||||
| ExAblate 2000 (InSightec Ltd, Haifa, Israel) 1.5T MR (Signa; GE Healthcare, Milwaukee, US) | Froling V et al, 2014 (80) | Charite-Universitatsmedizin, Berlin | Single site cohort study | July 2001 to July 2012 | 783 premenopausal women (median age 44.2 years) | Technical report to evaluate technical eligibility for UAE and MRgHIFU |
| ExAblate 2000 (InSightec Ltd, Haifa, Israel) 1.5T MR (Signa; GE Healthcare, Milwaukee, US) | Froling V et al, 2013, 2013 (126;137) | Charite-Universitatsmedizin, Berlin | Comparative prospective longitudinal cohort study, MRgHIFU versus UAE | 2002 to 2009 | 121 women: MRgHIFU 57 women (mean age 36.2 years; range, 29.2–41.0 years) vs. UAE 64 women (mean age 42.7; range, 33.6–52.2 years) | Comparative cohort study to evaluate eligibility and compare reintervention rates, symptom relief, HRQOL between MRgHIFU and UAE |
| ExAblate 2100 UF V2 (InSightec Ltd, Haifa, Israel) 1.5T MR (Signa; GE Healthcare, Milwaukee, US) | Trumm C et al, 2013 (91) | Klinikum der Lugwig-Maximilians-Universitat Munchen- Grobhadern, Munich | Single site prospective cohort follow-up study | November 2010 to June 2011 | 115 women (mean age 42 years; range, 25–54) | Treatment effectiveness; to evaluate safety and technical success of the second-generation ExAblate 2100 UF V2 system |
| India | ||||||
| ExAblate 2000 (InSightec Ltd) 1.5T MR (Signa; GE Healthcare | Desai S et al, 2012 (95) | Jaslok Hospital and Research Center, Mumbai | Single site prospective longitudinal cohort study | July 2010 to December 2010 | 50 women (mean age 36.2 ± 8.3 years; range, 21–53) | Treatment effectiveness; to evaluate safety and treatment success at 6-month follow-up |
| ExAblate 2010 (InSightec Ltd) −1.5T MR (Signa; GE Healthcarel | Himabindu Y et al, 2014 (105) | GSL General Hospital, Andhra Pradesh | Single site prospective longitudinal cohort study | February 2011 to October 2011 | 32 consecutive women (mean age 36.6 ± 6.23 years; range, 21–48) | Treatment effectiveness; to evaluate safety and treatment success at 6-month follow-up |
| ExAblate 2000 (InSightec Ltd., Haifa, Israel) 1.5T MR (Signa; GE Healthcare, Milwaukee, US) | Nyapathy V et al, 2012 (139) | GSL General Hospital, Andhra Pradesh | Case report | NR | 44-year-old nulliparous woman | Technical report; to evaluate treatment success of MRgHIFU for fibroids with hyperintense signalling characteristics on MR T2WI fibroids and associated with urinary retention |
| Israel | ||||||
| ExAblate 2000 (InSightec Ltd., Haifa, Israel) 1.5T MR (Signa; GE Healthcare, Milwaukee, US) | Machtinger R et al, 2012 (92) | Sheba Medical Center, Tel Hashomer | Single site prospective longitudinal cohort study | 2003 to 2008 | 87 premenopausal women (mean age 45.6 years ± 4.1; range, 36–53 | Treatment effectiveness; to evaluate factors associated with long-term success |
| ExAblate 2000 (InSightec Ltd, Haifa, Israel) 1.5T MR (Signa; GE Healthcare, Milwaukee, US) | Rabinovici J et al, 2010 (140) | 13 sites in 7 countries -reports from trials in and outside the US where desire for future pregnancy was an exclusion criteria; from 4 international sites where trial was designed for women specifically trying to conceive; and on pregnancies occurring in commercial treatment | Case series, regulatory reporting requirement | NR | 54 pregnancies in 51 women (mean age 37.2 ± 4.6 years; range, 28–49) | Reproductive report to evaluate pregnancy and obstetrical outcomes after HIFU |
| ExAblate 2000 (InSightec Ltd, Haifa, Israel) 1.5T MR (Signa; GE Healthcare, Milwaukee, US) | Rabinovici J et al, 2006 (125) | Sheba Medical Center, Tel Hashomer | Case report from ongoing study of MRgHIFU for benign uterine conditions | NR | 36-year-old woman | Reproductive report; a pregnancy and live birth report following MRgHIFU for adenomyotic uterus |
| Japan | ||||||
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (Signa; GE Healthcare Milwaukee, WI) | Funaki K et al, 2007 (72) | Shinsuma Hospital, Kobe | Single site prospective longitudinal cohort study | June 2004 to October 2005 | 63 women (mean age 40.5 years; range, 30–47) | Technical report to evaluate the relationship of fibroid reduction at 6-month follow-up to baseline signal intensity on pretreatment T2-weighted MR imaging of fibroids |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (Signa; GE Healthcare, Milwaukee, WI) | Funaki K et al, 2007 (72) | Shinsuma Hospital, Kobe | Single site prospective longitudinal cohort study | Beginning in 2004 | 35 women (median age 41 years; range, 30–48) | Technical report to evaluate the relationship of fibroid reduction at 12-month follow-up to baseline signal intensity on pretreatment T2-weighted MR imaging of fibroids |
| ExAblate 2000 version 4.1 or version 4.2 (InSightec, Haifa, Israel) 1.5T MR (Signa; GE Healthcare Milwaukee, WI) | Funaki K et al, 2009 (73) | Shinsuma Hospital, Kobe | Single site prospective longitudinal cohort study | June 2004 to June 2008 | 91 premenopausal women (mean age 40.4 ± 4.6 years) | Treatment effectiveness; to evaluate symptom improvement and fibroid volume change at 24-month follow-up |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (Signa; GE Healthcare Milwaukee, WI) | Fukunishi H et al, 2007 (99) | Shinsuma Hospital, Kobe | Case report | NR | 40-year-old woman (gravida 0) | Safety report; detection of unsuspected leiomyosarcoma |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Mikami K et al, 2008 (90) | Osaka University Graduate School of Medicine, Osaka | Single site retrospective cohort study | April 2003 to March 2004 | 48 women (mean age 44 years; range, 30–49) | Treatment effectiveness; to assess feasibility and effectiveness of MRgHIFU treatment at 12-month follow-up |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcarel Systems, Milwaukee, WI) | Morita Y et al, 2008 (96) | Itabashi Chuo Medical Center, Tokyo | Single site prospective longitudinal cohort study | January 2005 to February 2006 | 48 premenopausal women (mean age 42.6 ± 5.8 years; range, 24–51) | Technical report; to evaluate the relationship between the degree of uterine fibroid reduction and the degree of ablation by non-perfused volume |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare Milwaukee, WI) | Morita Y et al, 2009 (70) | Itabashi Chuo Medical Center, Tokyo | Single site prospective longitudinal cohort study | January 2005 to March 2006 | 83 premenopausal women (mean age 43 ± 5 years; range, 24–51) | Technical report; to evaluate the safety of MRgHIFU in relation to distance between treatment zone and uterine serosa at 12-month follow-up |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Morita Y et al, 2007 (123) | Itabashi Chuo Medical Center, Tokyo | Case report | NR | 29-year-old woman | Reproductive report; pregnancy outcome following MRgHIFU |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Okada A et al, 2009 (106) | 4 sites: Iseikai Hospital, Osaka; Itabashi Chuo Medical Center, Tokyo; Shinsuma General Hospital, Kobe; Aizu Chuo Hospital, Aizuwakamatsu | Multicentre prospective longitudinal cohort study | April 2003 to May 2006 | 287 women (mean age 42.5 ± 5.3 years; range, 24–60) | Technical report; to describe the learning curve effect of MRgHIFU for uterine fibroids over 12-month follow-up |
| Korea | ||||||
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI | Kim KA et al, 2011 (100) | CHA Gangnam Medical Center, Seoul | Case report | NR | 38-year-old woman | Safety report; spontaneous vaginal expulsion of ablated uterine fibroid |
| Sonalleve (Philips Healthcare, 1.5T MR (Achieva, Philips Healthcare, US) | Kim YS et al, 2012 (141;142) | Samsung Medical Center, Seoul | Retrospective cohort study | December 2010 to June 2011 | 27 women (mean age 44.5 ± 3.8 years; range, 35–50) | Technical report to evaluate initial clinical outcomes of HIFU one-layer strategy to treat large (> 10 cm in diameter) fibroids |
| Sonalleve (Philips Healthcare 1.5T MR (Achieva, Philips Healthcare, US) | Kim YS et al, 2012 (143) | 4 sites: Samsung Medical Center, Seoul, Korea; University Hospital Bordeaux, Segalen, France; University Medical Center, Utrech, Netherlands; University Hospital Schleswig-Holstein, Lubeck, Germany | Multicentre prospective cohort study | March 2009 to March 2010 | 33 pre- or peri-menopausal women (mean age 44.8 ± 5.2 years; range, 33–59) | Technical report to assess the accuracy and safety margin of volumetric HIFU based on MR thermometric analysis and effects of a feedback control technique |
| Sonalleve (Philips Healthcare 1.5T MR (Achieva, Philips Healthcare, US) | Kim YS et al, 2014 (88) | Samsung Medical Center, Seoul | Single site retrospective cohort study | December 2010 to August 2012 | 71 pre- or peri-menopausal women (mean age 43.3 years; range, 25–52) | Technical report to evaluate the relationship between intra-procedural thermal parameters and immediate or delayed therapeutic response |
| Sonalleve (Philips Healthcare,) 1.5T MR (Achieva, Philips Healthcare, US | Park MJ et al, 2013 (89) | Samsung Medical Center, Seoul | Single site retrospective cohort study | August 2009 to August 2011 | 43 women (mean age 43.7 ± 3.8 years; range, 35–50) | Technical report to examine factors affecting treatment speed of volumetric ablation including learning curve effects |
| Sonalleve (Philips Healthcare 1.5T MR (Achieva, Philips Healthcare, US) | Park MJ et al, 2013 (67) | Samsung Medical Center, Seoul | Single site retrospective case series | August 2010 to August 2012 | 13 women (mean age 40.5 ± 5.2 years; range, 34–52) | Technical report to evaluate a bowel manipulation technique to decrease screening failure rate |
| Sonalleve (Philips Healthcare,) 1.5T MR (Achieva, Philips Healthcare, US) | Park MJ et al, 2014 (82) | Samsung Medical Center, Seoul | Single site retrospective longitudinal cohort study | January 2011 to April 2012 | 79 women (mean age 43.6 ± 4.4 years; range, 34–52) | Treatment effectiveness; to evaluate the safety of complete or near-complete ablation and therapeutic efficacy at 3-month follow-up |
| ExAblate ExAblate 2000 (InSightec, Haifa, Israel) 3.0T MR (Signa HD, GE Healthcare, Milwaukee, WI) | Park H et al, 2012 (144) | CHA Bundang Medical center, Gyunggi-do | Case series | March 2007 to March 2009 | 135 women: 9 with pedunculated subserosal fibroid (mean age 39 years; range 25–47) | Treatment effectiveness; to evaluate outcomes of HIFU for pedunculated subserosal fibroids at 6-month follow-up |
| ExAblate ExAblate 2000 (InSightec, Haifa, Israel) 3.0T MR (Signa HD, GE Healthcare, Milwaukee, WI) | Yoon SW et al, 2010 (145) | CHA Bundang Medical Center, Gyunggi-do | Case report | In 2009, HIFU 9 years after a prior UAE | 45-year-old premenopausal woman | Technical report to evaluate the safety and effectiveness of HIFU after previous UAE treatment |
| ExAblate 2000 (InSightec, Haifa, Israel) 3.0T MR (Signa HD, GE Healthcare, Milwaukee, WI) | Yoon SW et al, 2011 (68) | CHA Bundang Medical Center, Gyunggi-do | Single site prospective cohort study | April 2008 to December 2008 | 20 consecutive premenopausal women (mean age 41.1 ± 4.0 years; range, 33–51) | Technical report; safety and effectiveness of HIFU using a custom patch to cover abdominal scars |
| ExAblate 2000 (InSightec, Haifa, Israel) 3.0T MR (Signa HD, GE Healthcare, Milwaukee, WI) | Yoon SW et al, 2013 (111) | CHA Bundang Medical Center, Gyunggi-do | Single centre prospective longitudinal cohort study | August 2006 to May 2007 | 60 consecutive women (mean age 41.3 ± 6.3 years, range 30–52) | Technical report to evaluate the relationship between the degree of ablation and the safety and treatment outcomes at 12-month follow-up |
| ExAblate 2000 (InSightec, Haifa, Israel) 3.0T MR (Signa HD, GE Healthcare, Milwaukee, WI) | Yoon SW et al, 2010 (124) | CHA Bundang Medical Center, Seongnam | Case report | NR | 31-year-old woman G0, P0 | Reproductive report; pregnancy following MRgHIFU |
| Netherlands | ||||||
| Sonalleve (Philips Healthcare) 1.5T MR (Achieva, Philips Healthcare, US) | Voogt M et al, 2012 (146) | University Medical Center, Utrech | Case reports | March 2010 to May 2012 | 2 women (37 years, 48 years) | Technical report to evaluate safety and effectiveness of targeted uterine artery ablation along with HIFU of uterine fibroid |
| Sonalleve (Philips Healthcare) 1.5T MR (Achieva, Philips Healthcare, US) | Voogt M et al, 2012 (42) | 4 sites: University Medical Center, Utrech Netherlands; Hospital St. Andre Bordeaux, France; Samsung Medical Center, Seoul, Korea; University Hospital Schleswig-Holstein, Lubeck, Germany | Multicentre prospective cohort study | NR | 33 pre- or perimenopausal women (mean age 44.8 ± 5.2 years) | Technical report to assess safety and technical feasibility of volumetric MRgHIFU ablation |
| Sonalleve (Philips Healthcare,) 1.5T MR (Achieva, Philips Healthcare, US) | Ikink M et al, 2013 (112) | University Medical Center, Utrech | Single centre prospective longitudinal cohort study | March 2010 to May 2012 | 51 pre- or perimenopausal women (mean age 45.3 ± 4.1 years) | Treatment effectiveness; to assess treatment efficacy of volumetric MRgHIFU ablation at 6-month follow-up |
| Norway | ||||||
| Sonalleve (Philips Healthcare) 3.0T MR (Achieva, Philips Healthcare, US) | Dorenberg E et al, 2013 (147) | Oslo University Hospital, Oslo | Case series | January 2010 to March 2011 | 7 women (mean age 44.6 years; range, 39–51) | Technical report to assess the safety and technical success of the Sonalleve system with 3T MR imaging |
| United Kingdom | ||||||
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Medical Systems, Milwaukee, WI) | Smart O et al, 2006 (77) | St Mary's Hospital, London | Single site prospective cohort study | NR | 50 premenopausal women (mean age 42 ± 4.9 years; range, 35–53) | Comparative study to evaluate the effects of GnRH fibroid pretreatment in 27 women compared to 23 age-matched women without fibroid pretreatment prior to HIFU |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Zaher S et al, 2009 (81) | St Mary's Hospital, London | Single site prospective cohort study | September 2005 to December 2006 | 144 women (mean age 42.8 years; range, 22–57) | Technical report to evaluate patient eligibility or suitability |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Zaher S et al, 2010 (69) | St Mary's Hospital, London | Single site prospective cohort study | March 2006 to May 2008 | 25 women (mean age 37 years; range, 29–52) | Technical report to evaluate a technique to treat patients with abdominal scars |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Zaher S et al, 2010 (121) | St Mary's Hospital, London | Case report | February 2007 | 39-year-old woman | Reproductive report; pregnancy and delivery outcome following MRgHIFU |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Zaher S et al, 2011 (122) | St Mary's Hospital, London | Case report | January 2008 | 45-year-old woman | Reproductive report; in vitro fertilization pregnancy after MRgHIFU |
| NR | Leon-Villapalos J et al, 2005 (101) | St Andrew's Centre for Plastic Surgery and Burns, Essex | Case report | NR | 39-year-old woman | Safety report; full thickness abdominal burn |
| United States | ||||||
| ExAblate 2000 version 4.2 (InSightec, Dallas, Texas) 3.0T MR (GE Healthcare, Milwaukee, WI) | Arleo E et al, 2007 (78) | New York Presbyterian Hospital, New York | Single site retrospective cohort review | April 2005 to December 2005 | 333 women | Technical report to assess the clinical and technical eligibility for MRgHIFU |
| ExAblate 2000 (InSightec, Dallas, Texas) 1.5T MR (GE Healthcare, Milwaukee, WI) | Behera M et al, 2010 (79) | Duke University Medical Center, North Carolina | Single site retrospective cohort review | November 2007 to February 2009 | 169 women | Technical report to assess the clinical and technical eligibility of patients for MRgHIFU |
| ExAblate 2000 (InSightec, Dallas, Texas) 1.5T MR (GE Healthcare, Milwaukee, WI) | Bouwsma E et al, 2011 (118) | NR | Case report | August 2009 | 37-year-old Asian woman | Reproductive report; pregnancy outcome after MRgHIFU |
| ExAblate 2000 (InSightec, Dallas, Texas) 1.5T MR (GE Healthcare, Milwaukee, WI) | Fennessy F et al, 2007 (49) | 5 sites: Brigham and Women's Hospital Boston MA; Mayo Clinic, Rochester MN, Johns Hopkins University School of Medicine, Baltimore MD; RadNet Management, Los Angeles CA; Lahey Clinic, Burlington MA | Multicentre prospective longitudinal cohort phase 3 clinical trial | April 2003 to December 2004 (original treatment guidelines); post 2004 (modified guidelines) | 160 consecutive women (mean age 46 years ± 4.3; range, 35–58 years) | Comparative study to compare the clinical outcomes at 12 months comparing 2 treatment protocols |
| ExAblate 2000 (InSightec, Dallas, Texas) 1.5T MR (GE Healthcare, Milwaukee, WI) | Gavrilova-Jordan LP et al, 2007 (119) | Mayo Clinic, Rochester MN | Case report | NR | 38-year-old woman | Reproductive report; pregnancy case report after MRgHIFU |
| ExAblate 2000 (InSightec, Dallas, Texas) 1.5T MR (GE Healthcare, Milwaukee, WI) | Gorny K et al, 2011 (97) | Mayo Clinic, Rochester MN | Single site prospective longitudinal cohort study | March 2005 to December 2009 | 150 women (mean age 45.6 ± 5.5 years; range, 31.9–58.5) | Treatment effectiveness; to evaluate the clinical and safety outcomes at 12 month follow-up |
| ExAblate 2000 (InSightec, Dallas, Texas) 1.5T MR (GE Healthcare, Milwaukee, WI) | Gorny K et al, 2014 (115) | Mayo Clinic, Rochester MN | Single site prospective longitudinal cohort study | March 2005 to November 2011 | 211 women (mean age 45.6 ± 5.8 years; range, 30–58) | Treatment effectiveness; to evaluate the reintervention rates in long-term follow-up |
| ExAblate 2000 (InSightec, Dallas, Texas) 1.5T MR (GE Healthcare, Milwaukee, WI) | Hanstede M et al, 2007 (120) | Brigham and Women's Hospital, Boston MA | Case report | January 2005 | 40-year-old woman | Reproductive report; pregnancy case report after MRgHIFU |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Hesley G et al, 2006 (93) | Mayo Clinic, Rochester MN | Single site (part of multicentre trial) prospective cohort study | Beginning in July 2002 | 42 women (mean age 46 years; range, 38–54) | Treatment effectiveness; to describe early clinical experience at Mayo clinic |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Hindley J et al, 2004 (109) | 7 sites: Brigham and Women's Hospital, Boston, MA; Johns Hopkins School of Medicine, Baltimore MD; Mayo Clinic, Rochester MN; Sheba Medical Center, Tel Hashomer, Israel; Hadassah Medical Center, Jerusalem, Israel; Charite Medical Center, Berlin | International multicentre phase 3 clinical trial | NR | 107 women (mean age 44.8 ± 4.9 years; range, 30–58) | Treatment effectiveness; to evaluate the early treatment results and post-treatment fibroid changes at 6-month follow-up |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Kim HS et al, 2011 (114) | Johns Hopkins University School of Medicine, Baltimore MD | Single site prospective longitudinal cohort clinical study | NR | 40 consecutive pre- and peri-menopausal women (mean age 46 ± 4.5 years) | Treatment effectiveness; to evaluate the long-term (up to 3 years) safety and clinical efficacy of MRgHIFU |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | LeBlang S et al, 2010 (43) | University Image-Guided Therapy Center, Boca Raton FL | Single site retrospective cohort clinical study | October 2004 to February 2007 | 80 consecutively treated women (mean age 46 years; range, 34–55) | Technical report to assess degree ablation and shrinkage after FDA protocol for commercial trials |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Lenard Z et al, 2008 (113) | Brigham and Women's Hospital, Boston MA | Single centre prospective longitudinal cohort clinical study | February 2002 and December 2005 | 66 women (mean age 45.4 ± 4.4 years) | Technical report to evaluate MR predictors of treatment success defined by fibroid reduction and symptom relief at 12 months |
| ExAblate 2000 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Machtinger R et al, 2013 (107) | 9 US sites: Brigham and Women's Hospital, Boston MA; Johns Hopkins University School of Medicine, Baltimore MD; Mayo Clinic, Rochester MN; Radnet Beverley Hills CA; Lahey, Burlington MA; Sightline Houston, TX; North Texas Uterine Fibroid Institute, Dallas TX; UMRI Boca Raton FL; Virtua, Voorhees NJ | Phase 2/4 prospective multicentre cohort clinical trial | January 2005 to April 2006 | 137 women (mean age 44.8 ± 4.8 years; range, 34–53); includes 64 women from the phase 3 study and 73 women from the phase 4 study of African American women | Comparative study to compare the safety and effectiveness of MRgHIFU in African American versus non–African American women |
| ExAblate 2000 (InSightec, Haifa., Israel) 1.5T MR (GE Healthcare, Milwaukee, WI | Stewart E et al, 2003 (84) | 5 sites: Brigham and Women's Hospital, Boston MA; St Mary's Hospital, London; Sheba Medical Center, Tel Hashomer, Israel; Hadassah Medical Center, Jerusalem, Israel; Charite Medical Center, Berlin | Multicentre prospective clinical trial; patients at 3 sites underwent planned hysterectomy after MRgHIFU | NR | 55 pre- or perimenopausal women (mean age 46.3 ± 0.7 years; range, 36–57) | Technical report to evaluate the safety of MRgHIFU and the degree of induced necrosis in uterine fibroids under real-time thermal monitoring with MRI |
| ExAblate 2000 version 2.3 or 2.4 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Stewart E et al, 2007 (83) | 5 sites (MRgHIFU for Uterine Fibroid Group): Brigham and Women's Hospital, Boston MA; Johns Hopkins Hospital, Baltimore MD; Mayo Clinic, Rochester MN; St Mary's Hospital, London; Sheba Medical Center, Tel Hashomer, Israel | Multicentre prospective clinical trial; pooled data from 4 separate trials with treatment protocols reported to or mandated by FDA to assess 24-month clinical end points | February 2002 to March 2006 | 359 women from 4 study groups. Group 1: phase 3 pivotal study (109 women, mean age 45.3 ± 4.8 years); Group 2: phase 3 study continued access in Europe (65 women mean age 43.9 ± 6.4 years); Group 3: phase 3 continued access in the United States (160 women mean age 46.4 ± 4.4 years); Group 4: post-market African American study in the United States (82 women, mean age 44.1 ± 5 years) | Treatment effectiveness; to evaluate long-term (3-year follow-up) outcomes of MRgHIFU treatment |
| NR | Taran F et al, 2009 (133) | 14 sites. 7 sites for MRgHIFU: Brigham and Women's Hospital, Boston MA; Johns Hopkins Hospital, Baltimore MD; Mayo Clinic, Rochester MN, St Mary's Hospital, London; Sheba Medical Center, Tel Hashomer, Israel; Hadassah Medical Center, Jerusalem, Israel; Charite Medical Center, Berlin; 7 separate sites for hysterectomy | Comparative study MRgHIFU versus hysterectomy | NR | MRgHIFU 109 women (mean age 44.8 ± 4.9 years); hysterectomy 83 women (mean age 44.4 ± 5.6 years) | Comparative study to compare MRgHIFU with hysterectomy for complications, adverse events, and HRQOL |
| NA | Taran F et al, 2010 (64) | The first international symposium on FUS surgery in Washington, DC | Survey of conference participants | October 6–7, 2008 | 13 symposium participants (5 gynecologists, 8 radiologists) | Opinion survey to evaluate participants reported patient selection criteria for HIFU |
| ExAblate 2000 version 2.3 or 2.4 (InSightec, Haifa, Israel) 1.5T MR (GE Healthcare, Milwaukee, WI) | Tempany C et al, 2003 (86) | Brigham and Women's Hospital, Boston MA | Single site prospective phase 1/2 study | NR | 9 premenopausal women (mean age 43.3 years; range, 39–51) | Technical report to test the feasibility and safety of MRgHIFU and evaluate the degree of target ablation with histopathological correlation (HIFU was followed by hysterectomy within 30 days) |
| Sonalleve (Philips Medical Systems,) 1.5T MR (Achieva, Philips Healthcare, US) | Venkatesan A et al, 2012 (85) | 2 sites: NIH Center Interventional Oncology, Bethesda MD and St Luke's Episcopal Hospital, Houston TX | Multicentre phase 1 clinical trial | NR | 11 pre- or perimenopausal women (mean age 46 years; range, 30–55) | Technical report to evaluate the safety and targeting accuracy of Sonalleve HIFU and review the imaging to histopathological correlation of target ablation (HIFU was followed by hysterectomy within 30 days) |
Abbreviations: GnRH, gonadotropin-releasing hormone analogue; HRQOL, health-related quality of life; MR, magnetic resonance; MRgHIFU, magnetic resonance-guided high-intensity focused ultrasound; NA, not appropriate; NR, not reported; QOL, quality of life; RF, radiofrequency; UAE, uterine artery embolization; US, United States; USgHIFU, ultrasound-guided high-intensity focused ultrasound.; vs., versus.