Abstract
This was a prospective, longitudinal, multicenter, single-arm controlled trial, using independent core laboratory validation of MRI results, to establish the effectiveness and confirm the safety of the VizAblate® System in the treatment of symptomatic uterine fibroids. The VizAblate System is a transcervical device that ablates fibroids with radiofrequency energy, guided by a built-in intrauterine ultrasound probe. Fifty consecutive women with symptomatic uterine fibroids received treatment with the VizAblate System. Patients had a minimum Menstrual Pictogram score of 120, no desire for fertility, and met additional inclusion and exclusion criteria. The VizAblate System was inserted transcervically and individual fibroids were ablated with radiofrequency energy. An integrated intrauterine ultrasound probe was used for fibroid imaging and targeting. Anesthesia was at the discretion of each investigator. The primary study endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months. Secondary endpoints, reached at 6 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Qual...Continue Reading
References
Aug 1, 1990·British Journal of Obstetrics and Gynaecology·J M HighamR W Shaw
Feb 1, 1995·The Journal of the American Association of Gynecologic Laparoscopists·H A Goldfarb
Jul 5, 2001·Fertility and Sterility·K M WyattP M O'Brien
Jan 30, 2002·Obstetrics and Gynecology·James B SpiesSheila M Gonzalves
Jan 28, 2003·American Journal of Obstetrics and Gynecology·Donna Day BairdJoel M Schectman
Jan 16, 2004·BJOG : an International Journal of Obstetrics and Gynaecology·Isaac ManyondaAnna-Maria Belli
Feb 3, 2004·Obstetrics and Gynecology·UNKNOWN Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists
Nov 18, 2004·AJR. American Journal of Roentgenology·Jonathan HindleyFerenc Jolesz
Mar 5, 2005·American Journal of Obstetrics and Gynecology·Valentino BergaminiMassimo Franchi
Nov 2, 2005·Obstetrics and Gynecology·James B SpiesReena C Jha
May 15, 2007·Current Opinion in Obstetrics & Gynecology·Rebecca S Usadi, Paul B Marshburn
May 22, 2007·Surgical Endoscopy·Fabio GhezziMassimo Franchi
Jul 3, 2007·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Xin LuoXiao-yu Wang
Aug 2, 2007·Obstetrics and Gynecology·Elizabeth A StewartClare M C Tempany
Oct 4, 2007·Journal of Vascular and Interventional Radiology : JVIR·Carole J DembekJames B Spies
Jun 6, 2008·The Australian & New Zealand Journal of Obstetrics & Gynaecology·Hyun Hee ChoMee Ran Kim
Sep 5, 2008·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Tetsuya KatsumoriTaiki Nozaki
Apr 14, 2009·Fertility and Sterility·Hayden Homer, Ertan Saridogan
Aug 4, 2009·American Journal of Obstetrics and Gynecology·Linda D Bradley
Sep 25, 2009·Cardiovascular and Interventional Radiology·Gianpaolo CarrafielloCarlo Fugazzola
Jun 29, 2010·American Journal of Obstetrics and Gynecology·Sanne M van der KooijJim A Reekers
Sep 23, 2010·Obstetrics and Gynecology·Andrea S LukesGary A Shangold
Nov 4, 2010·Current Medical Research and Opinion·Donald M BushnellDonald L Patrick
Jan 5, 2011·Journal of Minimally Invasive Gynecology·Kyoung Ah KimJong Tae Lee
Feb 25, 2011·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Malcolm G MunroUNKNOWN FIGO Working Group on Menstrual Disorders
Oct 1, 2011·Obstetrics and Gynecology International·Siân JonesDavid Toub
Oct 26, 2011·Journal of Vascular and Interventional Radiology : JVIR·Richard D Shlansky-GoldbergMark Rosen
Jun 2, 2012·European Radiology·Wei WangJie Tang
Feb 28, 2013·Journal of Ultrasound in Medicine : Official Journal of the American Institute of Ultrasound in Medicine·Jeong Yeon ChoJinxiang Li
May 3, 2013·Obstetrics and Gynecology·Scott G ChudnoffErika Banks
Citations
Feb 27, 2016·Gynecological Surgery·Hans BrölmannDavid Toub
Oct 30, 2016·The British Journal of Radiology·Ning HaiMeijuan Jin
Dec 12, 2018·Obstetrics and Gynecology·Scott ChudnoffJosé Gerardo Garza-Leal
Feb 7, 2020·International Journal of Hyperthermia : the Official Journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group·Xiao Liang LinPing Liang
Nov 9, 2019·Journal of Laparoendoscopic & Advanced Surgical Techniques. Part a·Linda D BradleyLarry E Miller
Feb 5, 2019·Journal of Gynecologic Surgery·Jose Gerardo Garza-Leal
Aug 14, 2019·Journal of Gynecologic Surgery·Gregor PschadkaDavid Toub
Jul 2, 2020·ClinicoEconomics and Outcomes Research : CEOR·Elizabeth A BrooksApril Zambelli-Weiner
Mar 31, 2017·Current Obstetrics and Gynecology Reports·David B Toub
Oct 12, 2019·Journal of Gynecologic Surgery·Marlies BongersRicardo Felberbaum
Feb 12, 2020·BMC Women's Health·Julia L MagnayChristian Seitz
Apr 1, 2020·Journal of Gynecologic Surgery·Charles E Miller, Khadra M Osman
Feb 6, 2021·Seminars in Ultrasound, CT, and MR·Anna Maria IerardiGianpaolo Carrafiello
Aug 26, 2020·Journal of Minimally Invasive Gynecology·Adela G CopeElizabeth A Stewart
Feb 6, 2021·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Gregory ShifrinGregor Pschadka
Jul 10, 2021·Abdominal Radiology·Chin-Jung WangKit-Sum Mak
Sep 5, 2021·Reproductive Sciences·Jiahui ZhangBhuchitra Singh