Radiofrequency Ablation of Uterine Fibroids

• Sponsor: University of California, Davis (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00584207
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Duration (Months): 52
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids	Procedure: radiofrequency ablation	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Radiofrequency Ablation of Uterine Fibroids
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Jul 1, 2008

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Medical Center	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

• Principal Investigator: John P. McGahan, MD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00584207
• Other Study ID Numbers: 200412085
• First Posted: Jan 2, 2008
• Last Update Posted: Apr 23, 2009
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: uterine fibroids
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

No Results Posted as of Apr 23, 2009