Minimal Invasive versus Non Invasive treatment for symptomatic uterine fibroids: A randomized controlled trial comparing uterine artery embolization with magnetic resonance guided focused ultrasound (MINI TRIAL) - MINI TRIA

niversitair Medisch Centrum Utrecht0 个研究点目标入组 74 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•-Minimum age of 18 years
•-Patient is pre- or peri-menopausal
•-Diagnosis of uterine fibroids is confirmed with MRI
•-Patient suffers from symptomatic uterine fibroids (defined as a minimum Symptom Severity Score of 40 points)
•-Patient must provide written informed consent

•-Uterine size larger than 24 weeks of gestation
•-Dominant fibroid < 3 cm or > 12 cm diameter
•-Pedunculated uterine fibroids with a stalk diameter less than one third of the fibroid diameter (MRI)
•-Current pregnancy or desire for future pregnancy
•-Suspected gynaecologic malignancy
•-Extensive scarring along anterior lower abdominal wall
•-Scar tissue or surgical clips in the direct path of the FUS beam
•-Current gynaecologic infection
•-Presence of intra uterine device
•-Degenerated or calcified fibroids (evidenced by gadolinium non-enhancement on MRI)
•-Contra-indications for MRI scanning (e.g. pacemaker, severe claustrophobia, ferromagnetic objects in the body)
•-Contra-indications for the use of gadolinium based contrast agents (e.g. known allergy, or acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2))
•-Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participating patient as judged by the treating physician or the investigator

发起方

niversitair Medisch Centrum Utrecht