Spiers, Laura http://orcid.org/0000-0001-5639-0499
Gray, Michael
Lyon, Paul
Sivakumar, Shivan
Bekkali, Noor
Scott, Shaun
Collins, Linda
Carlisle, Robert
Wu, Feng
Middleton, Mark
Coussios, Constantin
Funding for this research was provided by:
National Institute for Health and Care Research
Article History
Received: 23 August 2022
Accepted: 24 July 2023
First Online: 23 September 2023
Declarations
:
: This study has been approved by the Cambridge Central (East of England) Research Ethics Committee, reference number 20/EE/0284. The study adheres to the Declaration of Helsinki.The study received competent authority from the Medicine and Healthcare products Regulatory Agency (MHRA) on 18th January 2021. Ethical approval by the East of England (Cambridge Central) National Research Ethics Service (NRES) Committee, UK was achieved 18th January 2021. Health Research Authority (HRA) approval was granted on 26th January 2021. The trial opened to recruitment on 17th June 2021 (delayed due to Covid-19 pandemic) and halted recruitment on the 31st of March 2021.Written and verbal versions of the participant information sheets and informed consent are presented to the participants by the attending investigator, and necessarily include: the exact nature of the study; the implications and constraints of the protocol; the known side effects and any risks involving in taking part. The participant is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal. The investigator will not undertake any study specific procedures until valid consent is obtained.
: Not applicable.
: FW was part of the original team that developed the high intensity focused ultrasound device used in this study. The patents for the device are held by the Chongqing Medical University (Chongqing, China), by whom FW was employed. FW does not receive royalties for the manufacture, sale, upkeep, or maintenance of the device used for treatment despite being involved in the original team that filed patents related to the device.The rest other authors declare no competing interests.