Microwave Ablation for Uterine Fibroids

NCT ID: NCT04073485

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-05
• Study Completion Date: 2023-03-31

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.

Conditions

Uterine Fibroid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microwave ablation

The uterine fibroid will be identified and located with ultrasonography. A microwave electrode appropriate for the size of target lesion is placed into the target lesion under ultrasound guidance. Appropriate microwave power and application time are selected to provide sufficient ablation coverage to the target lesion.

Group Type: OTHER

Microwave ablation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Simon Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Yu, Professor

Role: PRINCIPAL_INVESTIGATOR

DIIR, CUHK, Hong Kong

Locations

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

VIR-19-10

Identifier Type: -

Identifier Source: org_study_id