Post Market TRUST - U.S.A. Study

Symptomatic Uterine Fibroids Clinical Trial

Official title: The TRUST (Treatment Results of Uterine Sparing Technologies) U.S.A. Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The purpose of this study is to 1) evaluate the economic burden, safety and outcomes of three uterine-conserving treatment alternatives for symptomatic uterine fibroids: myomectomy, uterine artery embolization (UAE), and global fibroid ablation (GFA) using the Acessa™ System, and 2) meet the requirements of the U.S. Food and Drug Administration's 522 Order for post market surveillance In this study, subjects who have symptomatic uterine fibroids will be randomized to one of three uterine-conserving treatments based on the local standard of care. ;

Related Conditions & MeSH terms

• Leiomyoma
• Symptomatic Uterine Fibroids

• NCT number: NCT02163525
• Study type: Interventional
• Source: Acessa Health, Inc.
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2014
• Completion date: June 2024