Microwave ablation for uterine fibroids

Last Updated on 8 November 2021

Sponsor

Vascular and Interventional Radiology Foundation (www.virf.org)
Department of Imaging and Interventional Radiology, the Chinese University of Hong Kong

Study purpose

Thermal ablation techniques such as High-Intensity-Focused-Ultrasound (HIFU) and Percutaneous radiofrequency ablation (RFA) have been used for the treatment of uterine fibroids, with different techniques demonstrating different advantages in terms of treatment procedures and treatment effectiveness.  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 (5-11).

The aim of this study is to evaluate the clinical safety and effectiveness of MWA in treating patients with uterine fibroid. It was hypothesized that MWA is a safe and effective treatment for uterine fibroid.

Study design

This is a prospective study conducted in accordance to the Declaration of Helsinki and International Conference on Harmonisation-Good Clinical Practice (ICH-GCP).  Approval from the institutional review board is applied. Thirty patients will be recruited. A signed informed consent will be obtained from each patient.

Eligibility criteria

Inclusion Criteria:

  1. Symptomatic fibroids with or without focal adenomyoma
  2. Symptomatic adenomyoma
  3. Female gender
  4. Age above 30
  5. Pre or peri menopausal with FSH less than 40 mIU/ml
  6. Negative urine pregnancy test
  7. Uterine size less than 22 weeks based on physical exam assessment
  8. Dominant fibroid or adenomyoma greater than or equal to 3 cm and less than or equal to 7 cm on imaging.
  9. Good health other than history of leiomyomas. Chronic medications may be acceptable at the discretion of the research team
  10. Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of  contraception and are willing to continue using them throughout the study
  11.  Willing and able to give informed consent
  12. Willing and able to comply with study requirements.
  13. 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 endpoints

  1. Technical success of treatment procedure
  2. Adverse effects and complications
  3. Volume change of the fibroids
  4. Symptomatology
  5. Quality of life (QOL)

Study location

Prince of Wales Hospital

Principal investigators

Professor Simon Chun-Ho Yu