Clinical trial NCT04073485: Microwave Ablation for Uterine Fibroids
Official title: Microwave Ablation for Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Fibroid
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 6
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of technical success
timeFrame: within one hour
Secondary outcomes:
measure: Assessment of adverse effects and complications
timeFrame: up to 18 months
measure: Assessment of volume change of the fibroids
timeFrame: 15 months after treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: DIIR, CUHK, Hong Kong
name: Simon Yu, Professor
role: PRINCIPAL_INVESTIGATOR
References: