Sonalleve With Direct Skin Cooling: Proof of Concept

Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU)With Direct Skin Cooling: Proof of Concept Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24730

Enrollment

Registered

2013-09-27

Start date

2013-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Leiomyoma Adenomyosis Vleesbomen

Interventions

Study subjects will receive their MR-HIFU treatment with a Philips Sonalleve MR-HIFU system equipped with a Direct Skin Cooling device. The Direct Skin Cooling Device keeps the interface between the

Eligibility

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 treatment with Direct Skin Cooling Device 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

Measure	Time frame
Incidence of Adverse Events 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. 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.	—

Measure

Time frame

Incidence of Adverse Events 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. 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.

—

Contacts

Public ContactMarjolein Breugel, van

University Medical Center Utrecht, Department of Radiology, Postbus 85500,

j.m.m.vanbreugel@umcutrecht.nl088 755 6687

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)