Prospective, monocentric, single-arm study investigating the safety and efficacy of local ablation of symptomatic uterine fibroids with US-guided high-Intensity focused ultrasound (HIFU) - HIFU-MT16

niversitätsklinikum Bonn0 个研究点目标入组 20 人开始时间: 2023年5月10日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Written documented informed consent to participate in the study
•-Patients who are able to follow study instructions and are likely to attend all required study visits (compliance)
•-Patients with symptomatic uterine fibroids who refuse surgical therapy and patients with increased risk of perioperative morbidity
•-Symptomatic uterine fibroid patients with indication for HIFU treatment
•-The uterine fibroid can be adequately visualized sonographically in the abdominal/back position and has a minimal diameter of 2 cm, no evidence of malignancy on imaging
•-Safe acoustic access to the fibroid is available
•-Distance between the skin surface and the deepest focus in the tumor max. 11 cm
•-MRI suitability of the patient

•- Age <18 years
•- Pregnancy or breastfeeding period
•- Suspected malignancy
•- Pathological cancer screening smear
•- Acute cystitis
•- Acute infection (e.g. pneumonia)
•- Pedunculated fibroids, subserous fibroids
•- Kelloid of the skin or in the acoustic access pathway
•- Ileal conduit
•- Concurrent participation in a clinical trial with ingestion of an investigational product up to 30 days prior to participation in this clinical trial

发起方

niversitätsklinikum Bonn