None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : Confirmation of operation possibility through Magnetic resonance imaging and Ultrasound before operation
Fasting more than 6 hours at the procedure day
End of proce
Sponsors
ALPINION MEDICAL SYSTEMS
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Adult women over 20 years old 2. Premenopausal or postmenopausal (FSH(Follicle stimulating hormone) <40mIU / ml) 3) Clinically diagnosed adenomyosis with MR(Magnetic resonance imaging) or US(Ultrasound) imaging 4) Clinical findings based on MR or US images suggest that focal adenomyosis is localized in the uterine adenomyoma 5) If the pain score on the dysmenorrhea index is 4 points or more 1 = Not at all 2 = A little bit 3 = Somewhat 4 = A great deal 5 = A very great deal 6) If you have not received any other treatment for adenomyosis within 3 months before the HIFU(High Intensity Focused Ultrasound) procedure 7) If you voluntarily agree to the clinical trial and you are willing to follow the test plan 8) Those who agree to use medically accepted contraception during the trial if there is a possibility of pregnancy. *Medically acceptable contraceptive methods: condoms, oral contraception for at least 3 months, use of contraceptives for injection or use, placement of intrauterine contraceptive devices, etc.
Exclusion criteria
Exclusion criteria: 1) Other pelvic diseases such as other malignancies, endometriosis, ovarian tumors, acute pelvic disease 2) Clinically suspected Sarcoma 3) Diffuse adenomyosis in which uterine adenomyoma is spread to the uterus 4) In case the pregnancy is positive or the pregnancy is desired 5) Severe systemic disease 6) Less than 25% of hematocrit 7) If there is a wide abdominal scar in the area where the ultrasound light passes 8) In case of a surgical clip or scar in the passageway through which a high-strength focused ultrasound passes 9) If you can not lie down in a comfortable position 10) MRI taboo (including clause phobia) 11) Contraindications to MRI contrast agents 12) Contraindications to Ultrasound contrast agents 13) GFR (glomerular filtration rate) is less than 30 ml / min 14) When communication is difficult 15) Patients who have participated in other clinical trials within the last month 16) Others, if judged by the investigator to be inappropriate for participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dysmenorrhea improvement rate;safety(side effects) | — |
Secondary
| Measure | Time frame |
|---|---|
| Dysmenorrhea improvement rate;Dysmenorrhea Score;menorrhagia Core;Measure the quality of life;Uterine size;Treatment satisfaction(5 point scale) | — |
Countries
Korea, Republic of
Contacts
Public ContactSoo Yeon Kang
Seoul National University Hospital
Outcome results
None listed