Clinical Test of the MRgHIFU System on Uterine Fibroids
MRgHIFU
For Research Purpose the Clinical Test of the Magnetic Resonance Imaging Guided Focused Ultrasound Ablation System on Uterine Fibroids
1 other identifier
interventional
20
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 28, 2014
CompletedFirst Posted
Study publicly available on registry
November 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedNovember 5, 2014
October 1, 2014
8 months
October 28, 2014
November 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Check Adverse Event or Serious Adverse Event
follow up
six month
Secondary Outcomes (2)
Using MRI to confirm the volume of the fibromyoma.
Screen, after treatment 1Month, 3Month, 6Month
Using quality of life questionnaire to compare quality of life that before and after treatment
Screen, after treatment 1Month, 3Month, 6Month
Study Arms (1)
Intervention: MRgHIFU, Surgery
EXPERIMENTALMagnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids
Interventions
Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chin-Jung Wanglead
- National Health Research Institutes, Taiwancollaborator
Study Sites (1)
Clinical Trial Center
Taoyuan District, Taiwan, 333, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chin-Jung Wang, MD
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, MD
Study Record Dates
First Submitted
October 28, 2014
First Posted
November 5, 2014
Study Start
September 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
November 5, 2014
Record last verified: 2014-10