D25.1
Conditions
Interventions
Group 1: Local US-guided HIFU treatment of symptomatic uterine fibroids: The entire study duration per patient is 8 months, including the screening visit. The HIFU procedure typically lasts for 2-5 ho
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the safety and tolerability of local HIFU treatment in symptomatic uterine fibroids based on the number of adverse events occuring according to standardized protocols: incidents and product defects, adverse events or severe adverse events after HIFU classified according to CTCAE V5.0 (grade 1-5). In addition to the frequency of adverse events according to CTCAE V5.0, the following possible therapy-associated side effects are explicitly recorded: - Pain sensation during and immediately after HIFU (measured on the Visual nalog Scale 0-10, with 0 indicating "no pain", and 10 indicating "strongest pain imaginable"), - Pain sensation on the first post-interventional day (VAS 1-10) - Skin edema, skin redness, skin burn - Cystitis, vaginal discharge, vaginal bleeding - Ascites | — |
Secondary
| Measure | Time frame |
|---|---|
| -Evaluation of symptom severity score (SSS) and health-related quality of life score using UFS-QOL questionnaire (baseline scores versus scores 1 week, 3 months, and 6 months after HIFU procedure) -Evaluation of fibroid volume using MRI measurements (baseline volume versus volume 1 week, 3 months, 6 months after HIFU procedure) -Evaluation of the correlation between intervention parameters (sonication time, treatment time, total energy, energy per ml fibroid volume), achieved non-perfused volume, fibroid type according to Funaki classification, fibroid shrinkage over time -Evaluation of tissue stiffness properties of uterine fibroids using elastography measurements on ultrasound and MRI before and after HIFU procedure -Effects of HIFU treatment on blood parameters and early immune response | — |
Countries
Germany
Contacts
Public ContactMilka Marinova
Universitätsklinikum Bonn, Interdisziplinäres HIFU-Zentrum
Outcome results
None listed