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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02283502 |
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Date of registration:
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28/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Test of the MRgHIFU System on Uterine Fibroids
MRgHIFU |
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Scientific title:
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For Research Purpose the Clinical Test of the Magnetic Resonance Imaging Guided Focused Ultrasound Ablation System on Uterine Fibroids |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02283502 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chin-Jung Wang, MD |
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Address:
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Telephone:
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886-3-3281200 |
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Email:
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wang2260@cgmh.org.tw |
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Affiliation:
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Name:
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Chin-Jung Wang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Linkou Chang Gung Memorial Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Already sign in the Informed Consent Form?
2. The woman who want to operate the Hysteromyomectomy, and the volume of the fibromyoma
is between 5-10 cm, will be included?
3. Woman age between 35~45 years, and do not want to be pregnant
4. Abdominal circumference?95 ?.
5. No pregnant.
6. MRI compatible.
Exclusion criteria:
1. Pregnant or Breast-feeding.
2. MRI uncompatible.
3. Woman who has scar in Abdomen.
4. Immunodeficiency or cancer.
5. Use the clinical medicine before 3 month age.
6. The woman who will not follow the project. -
Age minimum:
35 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Uterine Fibroids
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Intervention(s)
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Device: MRgHIFU system
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Primary Outcome(s)
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Check Adverse Event or Serious Adverse Event
[Time Frame: six month]
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Secondary Outcome(s)
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Using quality of life questionnaire to compare quality of life that before and after treatment
[Time Frame: Screen, after treatment 1Month, 3Month, 6Month]
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Using MRI to confirm the volume of the fibromyoma.
[Time Frame: Screen, after treatment 1Month, 3Month, 6Month]
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Secondary ID(s)
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NHRI-CTC-067
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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