Microwave Ablation for Uterine Fibroids

  • STATUS
    Recruiting
  • End date
    Jun 27, 2023
  • participants needed
    30
  • sponsor
    Chinese University of Hong Kong
Updated on 28 February 2022
local anesthetic
leiomyoma
uterine fibroid
peri-menopausal
microwave ablation

Summary

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

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.

Details
Condition Uterine Fibroid
Treatment Microwave Ablation
Clinical Study IdentifierNCT04073485
SponsorChinese University of Hong Kong
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

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
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