The 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.
ID
Bron
Verkorte titel
Aandoening
Uterine Leiomyoma
Adenomyosis
Vleesbomen
Ondersteuning
(Performer: University Medical Center Utrecht)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Feasibility of treatment with Direct Skin Cooling Device<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.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
The 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.
Onderzoeksopzet
Day of MR-HIFU treatment
Day 30 after MR-HIFU treatment
Onderzoeksproduct en/of interventie
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 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.
Publiek
Marjolein Breugel, van
Utrecht
The Netherlands
088 755 6687
j.m.m.vanbreugel@umcutrecht.nl
Wetenschappelijk
Marjolein Breugel, van
Utrecht
The Netherlands
088 755 6687
j.m.m.vanbreugel@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3975 |
| NTR-old | NTR4189 |
| Ander register | NL45458.041.13 : DHF178586 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |