Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

TRUST Study: New Minimally Invasive Treatment for Uterine Fibroids

Researchers at Brigham & Women's and Brigham & Women's Faulkner Hospital seek 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.

Brigham and Women's Hospital Uterine Fibroids Women's Health Surgery
8 visits over 5 years
Estimated Time Commitment
Female, 18-50 years
May Be Eligible
Payment up to $275
May Be Offered
Personal health tracking, Office visit, Overnight stay, Surgical procedure
May Be Required
 
I Am Interested I Am Interested I Am Interested

This project is not recruiting.

Overview

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. 
 
A company called 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.
 


Why it is important

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.


What we hope to accomplish

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.

Principal Investigator

James A Greenberg, M.D.

Brigham and Women's Hospital

Public Profile

Who can participate

This study is open to women who are 18 years old or older with fibroids who want to keep their uterus. The fibroids must be 10 centimeters or less in size. All participants must be done with childbearing.


 

Who cannot participate


  • Women who still want to have children cannot participate.

  • Women with fibroids bigger than 10 cm cannot participate.

  • Women who cannot have laparoscopic surgery cannot participate.

What you may be asked to do

All participant will undergo surgery - either GFA or myomecomt - to treat their fibroids. In addition to the surgery, there are several questionnaires to complete. Before and immediately after surgery, there are office visits and exams. After surgery, the questionnaires are completed over the phone. 


Project activities may include:

  • Personal health tracking
  • Office visit
  • Overnight stay
  • Surgical procedure

Estimated Time Commitment

8 visits over 5 years

What You May Get

Study participants will receive $50.00 after completing the 4 to 8 week follow-up visit, $50.00 for the 3 month visit, $25.00 for completing each follow-up visit at 6, 12, 24, 36 and 48 months, and $50.00 for completing the final visit at 60 months (5 years)

Location


Travel

  • No travel required

Additional Information

Project Website

http://www.treatfibroids.com


ClinicalTrials.gov Identifier

NCT02163525


Study Phase

Phase 4: This project studies a drug or treatment that has already been approved by the FDA and studied in both healthy volunteers and participants with specific diseases or conditions. It will gather more information about long term safety and will help to understand how the drug or treatment can be most effective.


Participating Institutions


Funding Source

  • Industry
Top