Uterine fibroids
Conditions
Sponsors
Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Females aged 18 years or above, in the premenopausal stage, and without any plans for fertility in the past 6 months; 2) Premenopausal or perimenopausal individuals with follicle-stimulating hormone (FSH) levels below 40 mIU/ml; 3) Confirmed diagnosis of uterine fibroids through imaging examinations (B-ultrasound /MRI/CT); 4) Presence of a single fibroid or up to 6 multiple fibroids; 5) Negative results in CA125 tumor marker testing [14]; 6) Presence of assessable lesions, intramural fibroids with a diameter equal to or greater than 3 cm and less than or equal to 10 cm; 7) The distance from the bottom of the uterine fibroid to the upper surface of the sacrum should be greater than 2 cm; 8) Currently using contraception methods such as abstinence, mechanical methods (condoms, diaphragms), or sterilization and willing to continue using them throughout the entire study period; 9) Patients voluntarily signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with fibroids without safe sound channels and fibroids without effective sound channels, which are more common in some low and deep positions, and the cervical fibroids with maximum diameter 50% of the abdominal wall area) or scar tissue and surgical scab left by the acoustic channel; 14) Patients with intrauterine devices or other metal implants placed in the pelvis; 15) The size of the patient's pedunculated submucosal or subserosal fibroid is =5cm, and the diameter of the pedicle tissue is <25% of the maximum diameter of the fibroid; 16) Human immunodeficiency virus (HIV) positive persons; 17) Those with severe brain disease or other mental illness; 18) Those who frequently use sedatives, sleeping pills, tranquilizers or other addictive drugs; 19) Pregnant or lactating women; 20) Those who cannot determine the efficacy; 21) The patients have participated in other drug clinical trials 3 months before enrollment, or participated in other device clinical trials within 1 month before enrollment; 22) Other situations judged by the researcher to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of treatment 3 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The ablation rate of fibroid volume at 1 month, 3 months, and 6 months after surgery;Symptoms of uterine fibroids and health-related quality of life questionnaire scores before surgery, 1 month after surgery, 3 months after surgery, and 6 months after surgery;Tumor marker levels before surgery, 1 month after surgery, 3 months after surgery, and 6 months after surgery;Equipment performance evaluation;Non-Perfused Volume Ratio, NPVR;Uterine Fibroid Symptom and Quality of Life, UFS.QQL; | — |
Countries
China
Contacts
Public ContactYing Tao
Shanghai Sixth People’s Hospital
Outcome results
None listed