Radiofrequency Ablation of Uterine Fibroids - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00584207

Purpose

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.

Condition	Intervention	Phase
Uterine Fibroids	Procedure: radiofrequency ablation	Phase 0

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Radiofrequency Ablation of Uterine Fibroids

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment:	15
Study Start Date:	March 2004
Study Completion Date:	July 2008
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Intraoperative RFA of uterine fibroids

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584207

Locations

United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

John P. McGahan, MD

University of California, Davis

More Information

No publications provided

Responsible Party:	University of California, Davis Dept. of Radiology ( John McGahan, M.D. )
Study ID Numbers:	200412085
Study First Received:	December 21, 2007
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00584207 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by University of California, Davis:

uterine fibroids

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Myofibroma
Connective Tissue Diseases
Leiomyoma

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Neoplasms
Myofibroma

Neoplasms by Histologic Type
Connective Tissue Diseases
Neoplasms, Connective Tissue
Leiomyoma

ClinicalTrials.gov processed this record on September 10, 2009