Myoma uterine fibroid
Conditions
Interventions
None listed
Sponsors
Philips Medical Systems, MR Finland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient selected for MR-HIFU treatment of Uterine Fibroids or Adenomyosis. Age >= 18 years. Patient capable of giving informed consent in writing and able to attend study visits.
Exclusion criteria
Exclusion criteria: Discretion of the principal investigator, e.g. in presence of clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of MR-HIFU treatment with Sonalleve with Direct Skin Cooling will be measured by recording whether treatments are completed successfully using the investigational device. Treatment completion will be judged by the treating physician and recorded in the Case Report Form (CRF). The rate of successful treatment completion will be determined. An individual treatment is deemed successful if the treating physician is able to complete the treatment as planned using the MR-HIFU device with Direct Skin Cooling. If a treatment needs to be aborted before the desired ablation volume is achieved, as judged by the treating physician, it will be counted as a failure. If the backup CE-labeled Sonalleve device without Direct Skin Cooling needs to be used to complete the treatment, it will be counted as a failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following measurements will be performed to gain additional insight into safety and feasibility of the treatment with the Philips Sonalleve MR-HIFU device with Direct Skin Cooling: 1. Safety Endpoint: Incidence of adverse events and Serious Adverse Events will be recorded in the CRF, and their relatedness to the investigational device and the study in general will be assessed. 2. Physician Acceptance: Acceptance of the device by the treating physician will be evaluated by determination of the Net Promoter Score. After each treatment, the treating physician will be asked the question *How likely is it that you would recommend this device to your colleagues?* Answers will be recorded as a score from 0 to 10, with 0 being the least likely and 10 being the most likely. The result will be recorded in the CRF. | — |
Countries
Netherlands
Outcome results
None listed