Microwave Ablation for Uterine Fibroids
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Assessment of technical success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Assessment of technical success
Time Frame: within one hour
Technical success was defined as successful completion of the planned treatment of target lesions
Secondary Outcomes
- Assessment of adverse effects and complications(up to 18 months)
- Assessment of volume change of the fibroids(15 months after treatment)
Investigators
Simon Yu
Professor
Chinese University of Hong Kong