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
Eligibility Criteria
Inclusion
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 10cm on imaging.
- Good health other than history of leiomyomas. Chronic medications may be acceptable atthe discretion of the research team.
- Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods ofcontraception 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
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.
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
Connect with a study center
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong,
Hong KongSite Not Available

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