CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 114 enrolled
Drug / intervention
Global Fibroid Ablation (GFA) +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02163525
NCT02163525N/ACompleted
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The TRUST (Treatment Results of Uterine Sparing Technologies) U.S.A. Study

Acessa Health, Inc.·interventional·Posted Jun 13, 2014·Updated Sep 30, 2025

In Brief

A clinical study evaluating Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, and 1 other intervention for Symptomatic Uterine Fibroids. Completed, enrolled 114 participants across 9 sites.

Detailed Summary

This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids. In addition, data from this study is being used to satisfy the requirements of the United States Food and Drug Administration's 522 (post market surveillance) order.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Uterine Fibroids
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 13, 2014
Enrollment StartJun 12, 2014
Primary CompletionJul 1, 2019
Study CompletionSep 12, 2025
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 12.1 years ago

Interventions

Global Fibroid Ablation (GFA)procedure

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 Myomectomyprocedure

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)procedure

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.