Status:
TERMINATED
Microwave Ablation for Uterine Fibroids
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Uterine Fibroid
Eligibility:
FEMALE
30-50 years
Phase:
NA
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-F...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04073485
Start Date
September 5 2019
End Date
March 31 2023
Last Update
May 3 2023
Active Locations (1)
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1
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong