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

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)

Study Overview

• Status: Unknown
• Conditions: Uterine Fibroids
• Intervention / Treatment: Device: MRgHIFU system

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't have a good quality of life. The worse case is the fertility of patients with fibroids is hindered. The current clinical treatment is medication or surgery. Medication can only suppress the symptom temporarily when the hysterectomy method of removing part or all of uterus can cure the patient completely. However, the hysterectomy is an invasive operation and the women with fibroids who plan to have a baby don't accept this kind of treatment.

Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids has been developed and was approved by the US Food and Drug Administration (FDA) in 2004. The ultrasound waves emitted by the ultrasonic probe propagate through the skin, fat, muscle, soft tissues and converge on fibroids at focus. High energy/intensity at focus causes the thermal necrosis of the fibroid tissue in several seconds. The whole process of HIFU ablation of fibroids is monitored and guided by MR thermometery. The advantage of MR-HIFU modality includes no incision, outpatient treatment and few side effects.

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), to achieve the clinical trial at the Chang-Gung Memorial Hospitals of Linkou and to commercialize the self-developed MRgHIFU system. The mission is to conduct the first-stage clinical test for 10 women with symptomatic uterine fibroids and to make two sets of HIFU system. Meanwhile, the impact of quality of life and satisfaction with treatment of the patients diagnosed with symptomatic uterine fibroids will be analyzed.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention: MRgHIFU, Surgery; Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids	Device: MRgHIFU system; Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Check Adverse Event or Serious Adverse Event	follow up	six month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Using MRI to confirm the volume of the fibromyoma.	follow up difference of fibromyoma that before and after treatment	Screen, after treatment 1Month, 3Month, 6Month
Using quality of life questionnaire to compare quality of life that before and after treatment	follow up	Screen, after treatment 1Month, 3Month, 6Month

Collaborators and Investigators

• Sponsor: Chin-Jung Wang
• Collaborators: National Health Research Institutes, Taiwan
• Investigators: Principal Investigator: Chin-Jung Wang, MD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): May 1, 2015
• Study Completion (ANTICIPATED): May 1, 2015

Study Registration Dates

• First Submitted: October 28, 2014
• First Submitted That Met QC Criteria: November 2, 2014
• First Posted (ESTIMATE): November 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 5, 2014
• Last Update Submitted That Met QC Criteria: November 2, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; ultrasound; Uterine fibroid; non-invasive therapy
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: NHRI-CTC-067