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Radiofrequency Ablation of Uterine Fibroids

Primary Purpose

Uterine Fibroids

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
radiofrequency ablation
Sponsored by
University of California, Davis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring uterine fibroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • UC Davis Medical Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2007
Last Updated
April 21, 2009
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00584207
Brief Title
Radiofrequency Ablation of Uterine Fibroids
Official Title
Radiofrequency Ablation of Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
Unsufficient referrals for recruitment
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
uterine fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Description
Intraoperative RFA of uterine fibroids
Primary Outcome Measure Information:
Title
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.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. McGahan, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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Radiofrequency Ablation of Uterine Fibroids

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