Uterine fibroids
Conditions
Interventions
Case series:HIFU ablation
Sponsors
International Peace Maternity and Child Health Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Women aged >=18 years old, not menopausal; 2. If there is a surgical scar on the abdominal wall of the treatment area, it should be aligned with the skin, with texturemedium or soft, and there is no obvious attenuation behind the scar when scanning with diagnostic ultrasound; 3. Patients with clinically diagnosed uterine fibroids are further confirmed by ultrasound and magnetic resonance imaging; 4. The fibroids that can be observed by the ultrasound of this system, the maximum diameter of fibroids is between 2cm and 8cm; 5. The number of intermuscular fibroids with a diameter >=4cm does not exceed 3; 6. Non-pediculated subserosal fibroids; 7. The subjects agreed to participate in this trial, and have signed the informed consent form, with good compliance and can cooperate to complete the treatment.
Exclusion criteria
Exclusion criteria: 1. women during menstruation, lactation or pregnancy; 2. those who want to have children within half a year; 3. complete hematology must be collected within 2 weeks before the treatment of this product, and laboratory indicators of liver and kidney function must not meet any of the following conditions: Number of white cells 32; {BMI= weight/height^2 (kg/cm^2)} 15. body temperature >38 degree C; 16. subjects with Hb less than 6g/L; 17. patients with severe coagulation dysfunction or bleeding tendency; 18. uncontrolled diabetes mellitus and abnormal liver and kidney function; 19. serious cardiovascular and cerebrovascular diseases: unstable angina, myocardial infarction within half a year, arrhythmia requiring drug control, severe hypertension and heart failure; A history of cerebral infarction and cerebral hemorrhage in half a year; 20. there may be severe scars (severe abdominal scars, multiple abdominal surgeries, pelvic radiotherapy, abdominal lipid-reducing surgery, calcification in the surrounding tissues of the uterus, etc.) on the ultrasonic conduction pathway; 21. subjects who are participating in clinical trials of other drugs or medical devices; 22. those who cannot accurately communicate their feelings in treatment and have no full capacity for civil conduct; 23. the product should not be used when the investigator believes that focused ultrasound therapy may not be in the best interest of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-perfused volume ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Volume reduction ratio; | — |
Countries
China
Contacts
Public ContactYu-dong Wang
International Peace Maternal and Child Health Hospital
Outcome results
None listed