Radiofrequency Ablation of Uterine Fibroids

Uterine Fibroids Clinical Trial

Official title:

Radiofrequency Ablation of Uterine Fibroids

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00584207
• Other study ID #: 200412085
• Status: Terminated
• Phase: Phase 0
• First received: December 21, 2007
• Last updated: April 21, 2009
• Start date: March 2004
• Est. completion date: July 2008

Study information

• Verified date: April 2009
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Procedure:
• radiofrequency ablation
Intraoperative RFA of uterine fibroids

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 years	Yes