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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
History of Changes

December 21, 2007
April 21, 2009
March 2004
March 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00584207 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Radiofrequency Ablation of Uterine Fibroids
Radiofrequency Ablation of Uterine Fibroids

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.
Not Provided
Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uterine Fibroids
Procedure: radiofrequency ablation
Intraoperative RFA of uterine fibroids
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
July 2008
March 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584207
200412085
No
John McGahan, M.D., University of California, Davis Dept. of Radiology
University of California, Davis
Not Provided
Principal Investigator: John P. McGahan, MD University of California, Davis
University of California, Davis
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP