Benign Uterine Tumor
Conditions
Brief summary
Uterine benign tumor including myoma is the most common female benign pelvic tumor. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) has been considered to be a minimal invasive treatment. The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In this trial, the investigators will observe the possibility of complication and tumor response of treatment.
Interventions
The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In Uterine benign tumor female, the investigators will observe the possibility of complication and tumor response of treatment.
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Benign uterine fibroids. 2. Women over the age of 20. 3. Abdominal circumference \<100 cm. 4. The largest fibroids are ≥ 4 cm.
Exclusion criteria
1. Pregnant women or those with positive pregnancy test results. 2. Those with other pelvic diseases. 3. Those with immune diseases. 4. There are unsuitable interfaces in the ultrasonic treatment path. 5. Those with tumor calcification. 6. People with severe heart, blood vessel and kidney disease. 7. Those with abnormal coagulation function and low platelets. 8. Type III fibroids according to Funaki classification
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of tumour response | 3 month after treatment | Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging |
Countries
Taiwan
Contacts
Primary ContactKai-Wen Huang, MD, PhD
Outcome results
None listed