Clinical Test of the MRgHIFU System on Uterine Fibroids

NCT ID: NCT02283502

Last Updated: 2014-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-05-31

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'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.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention: MRgHIFU, Surgery

Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids

Group Type: EXPERIMENTAL

MRgHIFU system

Intervention Type: DEVICE

Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids

Interventions

MRgHIFU system

Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids

Intervention Type: DEVICE

Eligibility Criteria

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. -

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

Chin-Jung Wang

OTHER

Sponsor Role: lead

Responsible Party

Chin-Jung Wang

Associate Professor, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chin-Jung Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Clinical Trial Center

Taoyuan District, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chin-Jung Wang, MD

Role: CONTACT

wang2260@cgmh.org.tw

886-3-3281200 ext. 8251

Ho Yun Li, Master

Role: CONTACT

ginnylee6174@gmail.com

886-3-3281200 ext. 5157

Other Identifiers

NHRI-CTC-067

Identifier Type: -

Identifier Source: org_study_id