Microwave Ablation for Uterine Fibroids

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04073485
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 68.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroid	Procedure: Microwave ablation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Microwave Ablation for Uterine Fibroids
• Actual Study Start Date: Sep 5, 2019
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Assessment of technical success [within one hour]

   Technical success was defined as successful completion of the planned treatment of target lesions

Secondary Outcome Measures

1. Assessment of adverse effects and complications [up to 18 months]

   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

2. Assessment of volume change of the fibroids [15 months after treatment]

   Magnetic resonance imaging will be performed at 3 and 15 month after treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

• Principal Investigator: Simon Yu, Professor, DIIR, CUHK, Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Simon Yu, Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT04073485
• Other Study ID Numbers: VIR-19-10
• First Posted: Aug 29, 2019
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

No Results Posted as of Mar 11, 2022