Radiofrequency Ablation of Uterine Fibroids

This study has been terminated.
(Unsufficient referrals for recruitment)
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584207
First received: December 21, 2007
Last updated: April 21, 2009
Last verified: April 2009
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation of Uterine Fibroids

Resource links provided by NLM:


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:
    Procedure: radiofrequency ablation
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by University of California, Davis:
uterine fibroids

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 30, 2014