D25.1 N80.0
Conditions
Interventions
Group 1: It is a treatment with the mobile ultrasound-guided HIFU System of Mirabilis. The device is CE-marked for the treatment of uterine fibroids.
Sponsors
Klinik für Diagnostische und Interventionelle Radiologie, Universitätskliniken Bonn
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 years • Signed informed consent consent for treatment and study participation • Patients who are able to follow the study instructions and ikely to comply with all necessary study visits (compliance) • Uterine fibroids (at least one fibroid = 2 cm) • The fibroids can be sufficiently visualized and safely treated with the mobile HIFU device using ultrasound • Negative pregnancy test (ß-HCG test in serum) • MRI compatibility
Exclusion criteria
Exclusion criteria: • Present pregnancy or breastfeeding • Suspected malignancy of the uterus, including an abnormal cancer smear • Acute cystitis • Acute infection that according to the study doctor or anesthetist makes it impossible to perform the treatment (e.g. severe cold, pneumonia, bronchitis) • Fibroids cannot be adequately visualized with the mobile HIFU device, as they e.g. lie too far posterior or are covered by intestinal gas • Pedunculated fibroids • Subserous fibroids, fibroids in the posterior uterine wall • Fibroids smaller than 2 cm (method-specific) • Extended scarring in the acoustic pathway e.g. after previous surgery • Ileal conduit • No painkillers or analgetics can be administered • Known or ongoing abuse of medication, drugs or alcohol • Simultaneous participation in another clinical trial with taking an investigational medicinal product up to 30 days before participating in this clinical trial or using a medical device, which may influence the study carried out here
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main purpose of this clinical study is to evaluate prospectively and standardizedly the effectiveness and safety of local therapy with high-intensity focused ultrasound (HIFU) using a mobile device in patients with uterine fibroids. The expected total duration of the study is 30 months. • The study duration for the study patient is a total of 7 months (including 1 month between presentation and treatment) • Duration of treatment: 2-4 hours, intervention itself expected <1 hour • Observation phase after the procedure: 6 months The primary evaluation is based on the size reduction of the fibroids by determining the fibroid volume over time. • Comparison of the absolute fibroid volume (in ml) and the percentage change (expected reduction) over time: 3 months and 6 months after HIFU treatment compared to the corresponding baseline values. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Recording therapy-associated side effects • Recording the intervention parameters of the HIFU treatment • Evaluation of changes in fibroid-related symptoms and health-related quality of life | — |
Countries
Germany
Contacts
Public ContactOlga Ramig
Klinik für Diagnostische und Interventionelle Radiologie, Universitätskliniken Bonn
Outcome results
None listed