Spots Global Cancer Trial Database for Post Market TRUST - U.S.A. Study

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Trial Identification

Brief Title: Post Market TRUST - U.S.A. Study

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

Study ID: NCT02163525

Conditions

Symptomatic Uterine Fibroids

Interventions

Global Fibroid Ablation (GFA)

Abdominal or Laparoscopic Myomectomy

Uterine Artery Embolization (UAE)

Study Description

Brief 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.

Detailed 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.