Post Market TRUST - U.S.A. Study

NACompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

June 12, 2014

Primary Completion Date

July 31, 2019

Study Completion Date

September 12, 2025

Conditions
Symptomatic Uterine Fibroids
Interventions
PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

Trial Locations (9)

14642

University of Rochester Medical Center, Rochester

48322

Henry Ford Hospital, West Bloomfield

60637

University of Chicago Medicine and Biological Sciences, Chicago

INOVA, Falls Church

78731

Texas Fertility Center, Austin

90401

University of California, Los Angeles, Santa Monica

94598

Aspen Surgery Center/John Muir Hospital, Walnut Creek

30912-3360

Augusta University, Augusta

02130

Brigham and Women's Hospital, Jamaica Plain

Sponsors
All Listed Sponsors
lead

Acessa Health, Inc.

INDUSTRY