Microwave Ablation for Uterine Fibroids

Uterine Fibroid Clinical Trial

Official title:

Microwave Ablation for Uterine Fibroids

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04073485
• Other study ID #: VIR-19-10
• Status: Terminated
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 31, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

Intervention

Procedure:
• Microwave ablation
Ultrasonogram is performed to identify the fibroid or adenomyoma. A trocar needle is placed into the lesion under local anesthesia. The MWA procedure is performed using appropriate microwave power and application time are selected to provide sufficient ablation coverage to the target lesion.

Locations

Country	Name	City	State
Hong Kong	Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of technical success	Technical success was defined as successful completion of the planned treatment of target lesions	within one hour
Secondary	Assessment of adverse effects and complications	Adverse effects and complications will be recorded during each treatment procedure, during each hospital admission related to the treatment, during each clinical visit at 1, 3, 6, 12 and 18 months	up to 18 months
Secondary	Assessment of volume change of the fibroids	Magnetic resonance imaging will be performed at 3 and 15 month after treatment.	15 months after treatment