The TRUST Study: Investigating New Minimally Invasive Treatment for Uterine Fibroids
Researchers at Henry Ford Health System’s Women’s Health Services department are seeking women between age 18 and 50 who have completed child-bearing and are looking for treatment for uterine fibroids that will allow them to keep their uterus. The study is called the TRUST study, which is short for Treatment Results of Uterine Sparing Technologies.
What we are studying
We are doing this research to compare the outcomes of 2 procedures to treat uterine fibroids: Global Fibroid Ablation (GFA) and Myomectomy (surgical removal of fibroids from the uterus). Fibroids are growths that are benign (meaning non-cancerous) tumors of the uterus (womb). Fibroids can cause heavy bleeding, belly pain, pressure, frequent urination, and other problems.
Acessa Health Inc (Austin, Texas, United States) has developed a method for the treatment of fibroids. This method is called Global Fibroid Ablation (GFA) or the Acessa procedure. GFA uses radiofrequency (RF) energy to treat the fibroid utilizing a special treatment probe. Radiofrequency energy causes the fibroid to heat up. The GFA device is approved by the U.S. Food and Drug Administration (FDA) to treat uterine fibroids. We doing this study to determine how this newer procedure compares with the more traditional procedure, myomectomy.
What we hope to accomplish
Procedures to treat fibroids are very common and we want to better understand if a newer technologies such as GFA (Acessa) can make the recovery from fibroid surgery easier but with similar (or better) results and costs. We hope to demonstrate that GFA (Acessa) is an equally effective treatment for fibroids that is easier to perform than myomectomy and is associated with faster recoveries for patients and lower costs to insurance providers.
Who can participate
Women 18 or older with untreated fibroids who wish to receive treatment and avoid hysterectomy may be eligible to receive treatment through the TRUST (Treatment Results of Uterine Sparing Technologies) USA study. Information on the study can be found at www.ClinicalTrials.gov (search identifier: NCT02163525).
Please take a few minutes to view more in-depth information in the video presentation below.
If you are interested in participating or have questions, please contact our study coordinator via phone or email
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