Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of California, Davis |
---|---|
Information provided by: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00584207 |
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 |
Enrollment: | 15 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UC Davis Medical Center | |
Sacramento, California, United States, 95817 |
Principal Investigator: | John P. McGahan, MD | University of California, Davis |
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: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00584207 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
uterine fibroids |
Neoplasms, Connective and Soft Tissue Myofibroma Connective Tissue Diseases Leiomyoma |
Neoplasms, Muscle Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue |