Microwave Ablation for Uterine Fibroids

NCT04073485 | Terminated

• 1 other identifier: VIR-19-10
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (1)

• Assessment of technical success

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

  within one hour

Secondary Outcomes (2)

• Assessment of adverse effects and complications

  up to 18 months

• Assessment of volume change of the fibroids

  15 months after treatment

Study Arms (1)

Microwave ablation

OTHER

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

Interventions

Microwave ablation 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.

Microwave ablation

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Symptomatic fibroids with or without focal adenomyoma
• Female gender
• Age between 30 and 50
• Pre or peri menopausal with FSH less than 40 mIU/ml
• Negative urine pregnancy test
• Uterine size less than 22 weeks based on physical exam assessment
• Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 10 cm on imaging.
• Good health other than history of leiomyomas. Chronic medications may be acceptable at the discretion of the research team.
• Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study.
• Willing and able to give informed consent.
• Willing and able to comply with study requirements.
• Normal menstrual cycle with endometrial pathology excluded

You may not qualify if:

• History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)
• Other pelvic pathology as indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease
• Pregnant or Positive pregnancy test
• Unexplained vaginal bleeding
• Untreated severe cervical dysplasia
• Abnormal adnexal /ovarian mass
• Intrauterine device
• Known recent rapid growth of fibroids, defined as a doubling in size in 6 months
• Known bleeding tendency
• Contraindication to MRI due to severe claustrophobia or implanted metallic device.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Simon Yu, Professor

  DIIR, CUHK, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 29, 2019
• Study Start: September 5, 2019
• Primary Completion: March 9, 2023
• Study Completion: March 31, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)