Uterine Fibroid
Conditions
Brief summary
This study is aimed to evaluate the clinical safety and effectiveness of Microwave ablation (MWA) in treating patients with uterine fibroid.
Detailed description
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.
Interventions
PROCEDUREMicrowave ablation
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Symptomatic fibroids with or without focal adenomyoma 2. Female gender 3. Age between 30 and 50 4. Pre or peri menopausal with FSH less than 40 mIU/ml 5. Negative urine pregnancy test 6. Uterine size less than 22 weeks based on physical exam assessment 7. Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 10 cm on imaging. 8. Good health other than history of leiomyomas. Chronic medications may be acceptable at the discretion of the research team. 9. Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study. 10. Willing and able to give informed consent. 11. Willing and able to comply with study requirements. 12. Normal menstrual cycle with endometrial pathology excluded
Exclusion criteria
1. History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke) 2. Other pelvic pathology as indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease 3. Pregnant or Positive pregnancy test 4. Unexplained vaginal bleeding 5. Untreated severe cervical dysplasia 6. Abnormal adnexal /ovarian mass 7. Intrauterine device 8. Known recent rapid growth of fibroids, defined as a doubling in size in 6 months 9. Known bleeding tendency 10. Contraindication to MRI due to severe claustrophobia or implanted metallic device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of technical success | within one hour | Technical success was defined as successful completion of the planned treatment of target lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of adverse effects and complications | up to 18 months | 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 |
| Assessment of volume change of the fibroids | 15 months after treatment | Magnetic resonance imaging will be performed at 3 and 15 month after treatment. |
Countries
Hong Kong
Outcome results
None listed