Microwave Ablation for Uterine Fibroids

Last updated: April 28, 2023
Sponsor: Chinese University of Hong Kong
Overall Status: Terminated

Phase

N/A

Condition

Sarcoma (Pediatric)

Desmoid Tumors

Uterine Fibroids

Treatment

Microwave ablation

Clinical Study ID

NCT04073485
VIR-19-10
  • Ages 30-50
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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 10cm on imaging.
  8. Good health other than history of leiomyomas. Chronic medications may be acceptable atthe discretion of the research team.
  9. Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods ofcontraception 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

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 Design

Total Participants: 6
Treatment Group(s): 1
Primary Treatment: Microwave ablation
Phase:
Study Start date:
September 05, 2019
Estimated Completion Date:
March 31, 2023

Study 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.

Connect with a study center

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

    Hong Kong,
    Hong Kong

    Site Not Available

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