Radiofrequency Ablation of Uterine Fibroids

NCT00584207 | Terminated Early Phase 1

• 1 other identifier: 200412085
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroids

Keywords

uterine fibroids

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

radiofrequency ablation PROCEDURE

Intraoperative RFA of uterine fibroids

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Diagnosed with uterine leiomyomas (fibroids)
• Patient will undergo surgical hysterectomy
• Patient is willing to sign informed consent form

You may not qualify if:

• Patients with acute infection
• Patients with bleeding disorders
• Patients who are not candidates for surgery or general anesthesia

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• John P. McGahan, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: March 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: July 1, 2008
• Last Updated: April 23, 2009

Record last verified: 2009-04

Locations

US (1)