Clinical trial NCT02283502: Clinical Test of the MRgHIFU System on Uterine Fibroids
Official title: For Research Purpose the Clinical Test of the Magnetic Resonance Imaging Guided Focused Ultrasound Ablation System on Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Uterine Fibroids
Keywords: Uterine fibroid
magnetic resonance imaging
ultrasound
non-invasive therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2014-11-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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. -

Primary outcomes:
measure: Check Adverse Event or Serious Adverse Event
timeFrame: six month
Secondary outcomes:
measure: Using MRI to confirm the volume of the fibromyoma.
timeFrame: Screen, after treatment 1Month, 3Month, 6Month
measure: Using quality of life questionnaire to compare quality of life that before and after treatment
timeFrame: Screen, after treatment 1Month, 3Month, 6Month
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Clinical Trial Center
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chin-Jung Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: