Microwave Ablation for Uterine Fibroids

STATUS

Recruiting
End date

Jun 27, 2023
participants needed

30
sponsor

Chinese University of Hong Kong

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Updated on 28 February 2022

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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 Identifier	NCT04073485
Sponsor	Chinese University of Hong Kong
Last Modified on	28 February 2022

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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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Microwave Ablation for Uterine Fibroids