Clinical Test of the MRgHIFU System on Uterine Fibroids

Uterine Fibroids Clinical Trial

— MRgHIFU  

Official title:

For Research Purpose the Clinical Test of the Magnetic Resonance Imaging Guided Focused Ultrasound Ablation System on Uterine Fibroids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02283502
• Other study ID #: NHRI-CTC-067
• Status: Recruiting
• Phase: Phase 1
• First received: October 28, 2014
• Last updated: November 2, 2014
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2014
• Source: Chang Gung Memorial Hospital
• Contact: Chin-Jung Wang, MD
• Phone: 886-3-3281200
• Email: wang2260[@]cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

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

Locations

Country	Name	City	State
Taiwan	Clinical Trial Center	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chin-Jung Wang	National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Check Adverse Event or Serious Adverse Event	follow up	six month	Yes
Secondary	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	No
Secondary	Using quality of life questionnaire to compare quality of life that before and after treatment	follow up	Screen, after treatment 1Month, 3Month, 6Month	No