Clinical Test of the MRgHIFU System on Uterine Fibroids

Phase 1

• Conditions: Uterine Fibroids
• Interventions: Device: MRgHIFU system

• Registration Number: NCT02283502
• Lead Sponsor: Chin-Jung Wang

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.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2014-10
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-11-02
• Last Update Submitted: 2014-11-02
• Study First Posted: 2014-11-05
• Last Update Posted: 2014-11-05
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention: MRgHIFU, Surgery	MRgHIFU system	Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids

Primary Outcome Measures

Name	Time	Method
Check Adverse Event or Serious Adverse Event	six month	follow up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center; 🇨🇳 Taoyuan, Taiwan