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Sonalleve With Direct Skin Cooling: Proof of Concept


- candidate number15466
- NTR NumberNTR4189
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-sep-2013
- Secondary IDsDHF178586 NL45458.041.13
- Public TitleSonalleve With Direct Skin Cooling: Proof of Concept
- Scientific TitleSonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU)With Direct Skin Cooling: Proof of Concept Study
- ACRONYMSonalleve DISC Proof of Concept
- hypothesisThe primary hypothesis of the study is that there would be no clinical or technical issues preventing MR-HIFU treatments using the Direct Skin Cooling device to be completed successfully.
- Healt Condition(s) or Problem(s) studiedUterine leiomyomata, Adenomyosis, Fibroids
- Inclusion criteriaPatient 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 criteriaDiscretion 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2013
- planned closingdate30-sep-2014
- Target number of participants8
- InterventionsStudy 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 MR-HIFU system and the patients' skin at constant temperature (close to room temperature or slightly below) during the treatment. The MR-HIFU treatment will be performed according to the labeling of the CE-labeled MR-HIFU device without Direct Skin Cooling.
- Primary outcomeFeasibility 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 outcomeIncidence 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.
- TimepointsDay of MR-HIFU treatment Day 30 after MR-HIFU treatment
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Marjolein Breugel, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Maurice Bosch, van den
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Philips Medical Systems MR Finland
- Funding
(Source(s) of Monetary or Material Support)
Philips Medical Systems MR Finland
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD27-sep-2013 - 17-okt-2013


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