Clinical Trial Seeking Participants
PI: Dr. Fergus Coakley
The purpose of this study is to determine the safety and efficacy of MRI guided focused ultrasound (HIFU) for treating symptomatic uterine fibroids. IRB #9840
Why is this study being done?
Uterine fibroids are extremely common benign tumors occurring in 20-50% of women over 30 years of age. Depending on location and size, fibroids can produce very unpleasant symptoms for a patient including pain, heavy menstrual bleeding, pressure, bloating and urinary and bowel compression. Symptomatic fibroids impact a woman’s health and well- being in both lost work hours and reduced quality of life.
Current medical treatments include surgical removal of the fibroid, with hysterectomy still the most common surgical procedure for fibroids and drug therapy or other modalities being used less frequently. Surgical procedures often require anesthesia, hospital stays, and long recovery periods. For symptom relief, women wishing to preserve the uterus may choose less invasive procedures, such as myomectomy or uterine artery embolization (UAE).
The objective of this clinical trial is determine the safety and clinical effectiveness of a non-invasive MRI guided focused ultrasound Fibroid Therapy system for relief from uterine fibroids.
Who is eligible to participate?
Women who are between the ages of 18 and 50 whom:
- have fibroids
- have heavy periods
- are done having children
There are more things your doctor will check before deciding if you are a candidate for the study. This will be discussed at your first appointment if you are selected.
What is the compensation for this study?
Participants are eligible to receive up to $690 for their time related to this study which requires treatment and follow up visits and phone calls for up to 3 years.
Who do I contact for additional information?
To find out more information and to learn if you are qualified to participate call the Women’s Health Research Unit confidential recruitment line: 503 494-3666