uterine fibroids and adenomyoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1). At least 18 years old, non-menopausal or perimenopausal patients (within 12 months of menopause); 2). MR combined with clinically diagnosed uterine fibroids or adenomyoma; 3). The longest diameter of fibroids or adenomyoma is more than 3cm and less than or equal to 10cm; 4) Sign the written informed consent; 5). Able to participate in all study visits; 6). Ability to communicate personal feelings during treatment; 7). The lesion is within the reach of focused ultrasound; 8). The lesions are clearly visible on non-contrast MR images; 9). Uterine fibroids or adenomyomas can be enhanced on contrast MR images.
Exclusion criteria
Exclusion criteria: 1). Pregnant women, confirmed by serum/urine test at screening, or urine pregnancy test on the day of treatment; 2). Uterine size > 24 weeks; 3). Lactating patients; 4). Patients with acute pelvic inflammatory disease (PID); 5). Patients with local or systemic infection in acute phase; 6). Contraindications to MRI scanning: severe claustrophobia, weighing more than 250 IBS (lbs) (113Kg), implanted with ferromagnetic materials and/or contraindicated devices for MR scanning, known intolerance to MRI contrast agents (such as , gadolinium or magenvir), any other contraindications to MRI scanning; 7). Extensive abdominal scars on the sound beam path; 8). There is ovarian teratoma on the treatment path; 9). Known pelvic malignant or precancerous lesions; 10). Those who have an intrauterine device (IUD) on the treatment path and cannot be removed; 11). Those who are allergic to oxytocin; 12). Patients with heart disease should be used with caution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain score; | — |
Countries
China
Contacts
Xijing Hospital, Air Force Medical University