Radiofrequency Ablation of Uterine Fibroids
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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 |
- 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) |
-
Procedure: radiofrequency ablation
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| United States, California | |
| UC Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| 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 June 18, 2013