Therapeutic MRI-guided High Intensity Focused Ultrasound ablation of uterine fibroids - MRI-guided HIFU ablation of uterine fibroids

Philips0 个研究点目标入组 10 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。

•-Women, age between 18 and 59 years
•-Weight < 140kg
•-Pre- or peri-menopausal (FSH < 40 mIU/ml)
•-Uterine size < 24 weeks gestation
•-Transformed SSS score > 40
•-Cervical cell assessment by PAP: Normal, Low Grade SIL, Low risk HPV or ASCUS (Atypical Squamous Cells of Uncertain Significance) subtypes of cervical tissue
•-Dominant Fibroid (by diameter) >= 3 cm and <= 12 cm

•-Other Pelvic Disease (Other mass, endometriosis, ovarian tumour, acute pelvic disease)
•-Desire for future pregnancy
•-Significant systemic disease even if controlled (determined by intestigator or treating physician)
•-Positive pregnancy test
•-Hematocrit < 25%
•-Extensive scarring along anterior lower abdominal wall (>50% of area)
•-Scar tissue or surgical clips in the direct path of the HIFU beam
•-MRI contraindicated
•-MRI contrast agent contraindicated
•-Fibroids not quantifiable on MRI (number & volume measurements)
•-Calcifications around or throughout uterine tissues
•-Communication Barrier

发起方