Radiofrequency Ablation of Uterine Fibroids

Stopped early · Early Phase 1

Conditions studied: Uterine Fibroids

In brief

This research study is being conducted to evaluate the safety and effectiveness of ablation (destruction) of uterine leiomyomas (fibroids) using electrocautery heating guided by ultrasound. We are doing this to look for a less invasive method of treatment for patients with uterine fibroids. One method that is being used in other areas of the body to treat masses is radiofrequency electrocautery. This method may be performed for the treatment of uterine fibroids by placing a small diameter needle through the wall of the vagina into the fibroid guided by an ultrasound probe. An optional approach is to place the needle through the skin of the abdomen into the fibroid guided by an ultrasound probe. Once the needle is in the fibroid, the electrocautery current is applied and the fibroid is destroyed by heating. This would be done before hysterectomy (removal of the uterus). We are trying to test to see if this type of treatment can be applied to uterine fibroids. We are trying to develop radiofrequency electrocautery as one of the methods to treat fibroids without surgery.

Key facts

Study ID

NCT00584207

Run by

University of California, Davis

People needed

15

Starts

2004-03-01

Expected to finish

2008-07-01

Last updated by the study team

2009-04-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Diagnosed with uterine leiomyomas (fibroids)
• Patient will undergo surgical hysterectomy
• Patient is willing to sign informed consent form

You may not qualify if…

• Patients with acute infection
• Patients with bleeding disorders
• Patients who are not candidates for surgery or general anesthesia

Where it is running

• UC Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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