Radiofrequency Ablation of Uterine Fibroids

Early Phase 1

Terminated

• Conditions: Uterine Fibroids

• Registration Number: NCT00584207
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2007-03
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-02
• Study Completion: 2008-07
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-21
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Following the hysterectomy, the study pathologist will perform a histological examination of the treated fibroid specimen to determine the size and volume of the ablation that was created with radiofrequency electrocautery.	3 years

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States