NCT01563783

Post Market TRUST Study

The Trust (Treatment Results of Uterine Sparing Technologies) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Acessa Health, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Uterine fibroids are the most common pelvic neoplasms in women; they severely impact quality of life and are the leading indication for hysterectomy. Hysterectomy is the definitive treatment for myomas; however, many patients seek alternative uterine-sparing therapy and desire to conserve their fertility. Myomectomy is a much-reported surgical option for women with symptomatic fibroids and, until recently, the abdominal approach has been the approach of choice for most surgeons. Over time, patients have requested less invasive procedures and minimally invasive, laparoscopic options are becoming more popular among patients and their gynecologists. Standard surgical and interventional treatments for uterine fibroids are costly to society and to the health care system. New technologies such as GFA may offer a low-cost alternative to the standard treatments for symptomatic uterine fibroids in women who desire uterine conservation. This study seeks to evaluate those cost differences between three available uterine-sparing techniques and to explore the qualitative outcomes such as symptom severity, health related quality of life, and overall treatment effect.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
PROCEDURE	Global Fibroid Ablation (GFA)	GFA is being used for the treatment of symptomatic uterine fibroids
PROCEDURE	Abdominal or Laparoscopic Myomectomy	Myomectomy is a procedure in which uterine fibroids are surgically removed from the uterus.
PROCEDURE	Uterine Artery Embolization (UAE)	UAE is a minimally invasive surgical procedure used to treat uterine fibroids.

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-09-01
• Completion: 2022-06-01
• First posted: 2012-03-27
• Last updated: 2023-02-01

Locations

1 site across 1 country: Canada