A prospective study to evaluate the safety and efficacy of 'ALPIUS'(high intensity focused ultrasound) in patients with uterine leiomyoma

A prospective, single-center, single-group, Investigator initiated clinical trial to evaluate the safety and efficacy of 'ALPIUS' (US-guided HIFU System, ultrasound-guided high-intensity focused ultrasound)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003500

Enrollment

Registered

2019-02-13

Start date

2014-12-18

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : One time High intensity Focused Ultrasound treatment

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Adult women over 20 years old 2. Premenopausal or postmenopausal (FSH <40mIU / ml) 3. In case the clinician determines that the uterus size is less than 24 weeks of single pregnancy 4. If myoma is diagnosed by (Magnetic Resonance Imaging)MRI or US(Ultrasound) imaging 5. If myoma size is more than 3cm and less than 12cm 6. Unless (High Intensity Focused Ultrasound)HIFU has received other treatment for uterine fibroids 7. Treatment If the guidelines for selection of uterine myoma are met 8. Willing to voluntarily agree to the clinical trial and willing to follow the protocol 9. Those who agree to use medically acceptable contraception during the trial if there is a possibility of pregnancy. * Medically acceptable contraceptive methods: Condoms, oral contraception for at least 3 months,Injectable contraceptive or implantation contraceptives, intrauterine contraceptive device installed

Exclusion criteria

Exclusion criteria: 1. Other pelvic disorders such as other tumors, endometriosis, ovarian tumors, acute pelvic disease 2. If you are pregnant or you are pregnant 3. Severe systemic disease 4. Less than 25% hematocrit 5. If the extensive scarring along the anterior abdominal wall exceeds 50% of the area 6. High intensity focused ultrasound passes through scar, surgical clip 7. Magnetic Resonance Imaging(MRI) taboo (including closure phobia) 8. Megnetic Resonance Imaging(MRI) contrast agents taboo 9. Ultrasound contrast agents taboo 10. If the number or volume of uterine myomas can not be measured by MRI 11. If the glomerular filtration rate (GFR) is less than 30 ml / min 12. When communication is difficult 13. Can not lie down comfortably 14. Patients who have participated in other clinical trials within the past month 15. Hypervascular myoma 16. In addition, if it is judged by the researcher that participation in this trial is inappropriate

Design outcomes

Primary

Measure	Time frame
Successful ablation rate of uterine myoma	—

Secondary

Measure	Time frame
Quality of life;Re-intervention rate;ablated volume shrinkage rate;safety	—

Countries

Korea, Republic of

Contacts

Public ContactSoo Yeon Kang

Seoul National University Hospital

jumper6805@gmail.com+82-2-2072-3073

Outcome results