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
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring uterine fibroids
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
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
NCT ID
NCT00584207
First Posted
December 21, 2007
Last Updated
April 21, 2009
Sponsor
University of California, Davis
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
Learn more about this trial
Radiofrequency Ablation of Uterine Fibroids
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