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)

Not Applicable

Conditions: D25.1
Intramural leiomyoma of uterus

Registration Number: DRKS00017490

Lead Sponsor: niversitätsklinikum Bonn

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 20

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

- 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br><br>In addition to the frequency of adverse events according to CTCAE V5.0, the following possible therapy-associated side effects are explicitly recorded:<br>- 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),<br>- Pain sensation on the first post-interventional day (VAS 1-10)<br>- Skin edema, skin redness, skin burn<br>- Cystitis, vaginal discharge, vaginal bleeding<br>- Ascites

Secondary Outcome Measures

Name	Time	Method
-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)<br>-Evaluation of fibroid volume using MRI measurements (baseline volume versus volume 1 week, 3 months, 6 months after HIFU procedure)<br>-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<br>-Evaluation of tissue stiffness properties of uterine fibroids using elastography measurements on ultrasound and MRI before and after HIFU procedure<br>-Effects of HIFU treatment on blood parameters and early immune response<br>