Status:
UNKNOWN
Clinical Test of the MRgHIFU System on Uterine Fibroids
Lead Sponsor:
Chin-Jung Wang
Collaborating Sponsors:
National Health Research Institutes, Taiwan
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
35-45 years
Phase:
PHASE1
Brief Summary
The objectives of this program are to verify the safety and effectiveness of the MRgHIFU system developed by the division of Medical Engineering of National Health Research Institutes (NHRI)
Detailed Description
Between 25 % - 50 % of women of childbearing age have uterine fibroids. Also, 25% of women with fibroids suffer from the metrorrhagia, menorrhagia, dysmenorrheal or pelvic compression so that they don...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Already sign in the Informed Consent Form。
- The woman who want to operate the Hysteromyomectomy, and the volume of the fibromyoma is between 5-10 cm, will be included。
- Woman age between 35\~45 years, and do not want to be pregnant
- Abdominal circumference≦95 ㎝.
- No pregnant.
- MRI compatible.
- Exclusion criteria:
- Pregnant or Breast-feeding.
- MRI uncompatible.
- Woman who has scar in Abdomen.
- Immunodeficiency or cancer.
- Use the clinical medicine before 3 month age.
- The woman who will not follow the project. -
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02283502
Start Date
September 1 2014
End Date
May 1 2015
Last Update
November 5 2014
Active Locations (1)
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1
Clinical Trial Center
Taoyuan District, Taiwan, Taiwan, 333