Radiofrequency Ablation of Uterine Fibroids

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00584207

Enrollment

Registered

2008-01-02

Start date

2004-03-31

Completion date

2008-07-31

Last updated

2009-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids

Keywords

uterine fibroids

Brief 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.

Interventions

PROCEDUREradiofrequency ablation

Intraoperative RFA of uterine fibroids

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026