Microwave Ablation for Uterine Fibroids

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

Study Overview

• Status: Terminated
• Conditions: Uterine Fibroid
• Intervention / Treatment: Procedure: Microwave ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Wong; Phone Number: (852) 35053210; Email: carmenwongsp@cuhk.edu.hk
• Study Contact Backup: Name: Pui Man Chong; Phone Number: (852) 35054094; Email: siuman@cuhk.edu.hk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 48 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of technical success	Technical success was defined as successful completion of the planned treatment of target lesions	within one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Assessment of volume change of the fibroids	Magnetic resonance imaging will be performed at 3 and 15 month after treatment.	15 months after treatment

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Simon Yu, Professor, DIIR, CUHK, Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: VIR-19-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No