Back to resultsMicrowave Ablation for Uterine Fibroids
Primary Purpose
Uterine Fibroid
Status
Terminated
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Microwave ablation
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroid
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Microwave ablation
Arm Description
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.
Outcomes
Primary Outcome Measures
Assessment of technical success
Technical success was defined as successful completion of the planned treatment of target lesions
Secondary Outcome Measures
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
Assessment of volume change of the fibroids
Magnetic resonance imaging will be performed at 3 and 15 month after treatment.
Full Information
NCT ID
NCT04073485
First Posted
August 28, 2019
Last Updated
April 28, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04073485
Brief Title
Microwave Ablation for Uterine Fibroids
Official Title
Microwave Ablation for Uterine Fibroids
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
poor patient accrual
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microwave ablation
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Microwave ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of technical success
Description
Technical success was defined as successful completion of the planned treatment of target lesions
Time Frame
within one hour
Secondary Outcome Measure Information:
Title
Assessment of adverse effects and complications
Description
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
Time Frame
up to 18 months
Title
Assessment of volume change of the fibroids
Description
Magnetic resonance imaging will be performed at 3 and 15 month after treatment.
Time Frame
15 months after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Yu, Professor
Organizational Affiliation
DIIR, CUHK, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Microwave Ablation for Uterine Fibroids
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