An interventional study of Microwave ablation in Uterine Fibroid, sponsored by Chinese University of Hong Kong. Terminated at 1 site in Hong Kong. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
This study is aimed to evaluate the clinical safety and effectiveness of Microwave ablation (MWA) in treating patients with uterine fibroid.
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.
496 studies on the registry are indexed under Leiomyoma; 79 are open to participants now.
This study's enrollment of 6 is below the median of 62 across 350 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
Assessment of technical success
Technical success was defined as successful completion of the planned treatment of target lesions
Time frame: within one hour
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
Time frame: up to 18 months
Assessment of volume change of the fibroids
Magnetic resonance imaging will be performed at 3 and 15 month after treatment.
Time frame: 15 months after treatment
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →