Radiofrequency Ablation of Uterine Fibroids
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.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Uterine Fibroids
Intervention
radiofrequency ablation
Location
UC Davis Medical Center
Sacramento
California
United States
95817
Status
Terminated
Source
University of California, Davis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00584207
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Endometrial Ablation Techniques
Procedures used for the targeted destruction of the mucous membrane lining of the uterine cavity.
Ablation Techniques
Removal of tissue by vaporization, abrasion, or destruction. Methods used include heating tissue by hot liquids or microwave thermal heating, freezing (CRYOABLATION), chemical ablation, and photoablation with LASERS.
Uterine Balloon Tamponade
Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.
Uterine Monitoring
Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.
Uterine Cervical Diseases
Pathological processes of the UTERINE CERVIX.
Clinical Trials
Laparoscopic Radiofrequency Ablation of Symptomatic Uterine Fibroids
The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibro...
The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bl...
The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues wil...
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation
The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate u...
The study objective is to develop data for the safety of pregnancies after thermal ablation of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.
PubMed Articles
Objective: To evaluate feasibility of Ultrasound-guided Radio Frequency Ablation (U-gRFA) for treatment of women with symptomatic uterine fibroids in relation to volume of fibroid. Methods: Forty-thre...
OBJECTIVE: The purpose of this prospective multicenter study was to assess the safety and technical feasibility of volumetric Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) abla...
OBJECTIVES: To evaluate the safety and efficacy of US-guided high-intensity focused ultrasound (HIFU) ablation for the treatment of submucosal fibroids METHODS: A total of 76 women with 78 submucosal...
OBJECTIVES: To assess the treatment speed of volumetric magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) ablation of symptomatic uterine fibroids, with a focus on factors affectin...
ABSTRACT: BACKGROUND: During the past 2 decades, there has been a rapid proliferation of for-profit "health examination center (HEC)" across China. The effects of their services on public's health hav...
