Sonalleve With Direct Skin Cooling: Proof of Concept
- Conditions
- terine LeiomyomaAdenomyosisVleesbomen
- Registration Number
- NL-OMON24730
- Lead Sponsor
- Philips Medical Systems MR Finland(Performer: University Medical Center Utrecht)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
Patient selected for MR-HIFU treatment of Uterine Fibroids or Adenomyosis
Age >= 18 years
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of treatment with Direct Skin Cooling Device<br /><br>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.
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events<br /><br>Incidence of adverse events and Serious Adverse Events will be recorded in the Case Report Form, and their relatedness to the investigational device and the study in general will be assessed. Specifically, the patients' skin will be inspected for any Adverse Events immediately after the treatment.<br><br /><br /><br>Physician Acceptance<br /><br>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.