Microwave Ablation for Uterine Fibroids

Study Overview
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Brief Summary
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This study is aimed to evaluate the clinical safety and effectiveness of Microwave ablation (MWA) in treating patients with uterine fibroid.

Detailed Description
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Percutaneous radiofrequency ablation (RFA) is another form of thermal ablation that has been used for the treatment of uterine fibroids. Although RFA is more invasive when compared to High-Intensity-Focused-Ultrasound (HIFU), the treatment is less limited by the location of the lesions, and the treatment procedure is more time efficient. To further improve the technology of thermal ablation for uterine fibroid, percutaneous microwave ablation (MWA) could be a promising option because it allows increased efficiency of energy transmission and reduction in procedure time, and may allow effective treatment of large lesions.

Official Title
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Microwave Ablation for Uterine Fibroids

Conditions
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Uterine Fibroid

Intervention / Treatment
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* Procedure: Microwave ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic fibroids with or without focal adenomyoma Female gender Age between 30 and 50 Pre or peri menopausal with FSH less than 40 mIU/ml Negative urine pregnancy test Uterine size less than 22 weeks based on physical exam assessment Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 10 cm on imaging. Good health other than history of leiomyomas. Chronic medications may be acceptable at the discretion of the research team. Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study. Willing and able to give informed consent. Willing and able to comply with study requirements. Normal menstrual cycle with endometrial pathology excluded Exclusion Criteria: History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke) Other pelvic pathology as indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease Pregnant or Positive pregnancy test Unexplained vaginal bleeding Untreated severe cervical dysplasia Abnormal adnexal /ovarian mass Intrauterine device Known recent rapid growth of fibroids, defined as a doubling in size in 6 months Known bleeding tendency Contraindication to MRI due to severe claustrophobia or implanted metallic device.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Microwave ablation<br>The uterine fibroid will be identified and located with ultrasonography. A microwave electrode appropriate for the size of target lesion is placed into the target lesion under ultrasound guidance. Appropriate microwave power and application time are selected to provide sufficient ablation coverage to the target lesion. | Procedure: Microwave ablation<br>* Ultrasonogram is performed to identify the fibroid or adenomyoma. A trocar needle is placed into the lesion under local anesthesia. The MWA procedure is performed using appropriate microwave power and application time are selected to provide sufficient ablation coverage to the target lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of technical success | Technical success was defined as successful completion of the planned treatment of target lesions | within one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse effects and complications | Adverse effects and complications will be recorded during each treatment procedure, during each hospital admission related to the treatment, during each clinical visit at 1, 3, 6, 12 and 18 months | up to 18 months | 
| Assessment of volume change of the fibroids | Magnetic resonance imaging will be performed at 3 and 15 month after treatment. | 15 months after treatment |