114
Participants
Start Date
June 12, 2014
Primary Completion Date
July 31, 2019
Study Completion Date
September 12, 2025
Global Fibroid Ablation (GFA)
GFA is radiofrequency ablation of fibroids. This is a laparoscopic procedure whereby a radiofrequency probe is inserted into the fibroid under laparoscopic and ultrasound guidance. Each fibroid is heated to temperatures averaging 95 deg C. The fibroid undergoes coagulative necrosis and shrinks and/or disappears.
Abdominal or Laparoscopic Myomectomy
Myomectomy is a procedure in which an incision is made into the uterus and the fibroids are surgically removed from the uterus. The uterine incision is closed with sutures. This procedure can be performed through an abdominal incision or via laparoscopy.
Uterine Artery Embolization (UAE)
UAE is a minimally invasive surgical procedure used to treat uterine fibroids. An embolic material is injected into the uterine artery(ies) to block blood flow to one or more fibroids. This procedure is performed by an interventional radiologist.
University of Rochester Medical Center, Rochester
Henry Ford Hospital, West Bloomfield
University of Chicago Medicine and Biological Sciences, Chicago
INOVA, Falls Church
Texas Fertility Center, Austin
University of California, Los Angeles, Santa Monica
Aspen Surgery Center/John Muir Hospital, Walnut Creek
Augusta University, Augusta
Brigham and Women's Hospital, Jamaica Plain
Lead Sponsor
Acessa Health, Inc.
INDUSTRY