On September 1, 2018, the kick-off meeting of "SUA-I HIFU System"clinical trial was held in International Peace Maternity & Child Health Hospital of China welfare institute (IPMCH). Professor Jingfeng Bai, Vice President of School of Biomedical Engineering from Shanghai Jiaotong University; Professor Xiang Ji from Shanghai Jiaotong University; Yudong Wang, director of International Peace Maternity & Child Health Hospital of China welfare institute (IPMCH); Yuanhuan Xiong, chief physician of Jiangxi people's Hospital; Chuanliang Tong, director of institutional office and other experts participated in the meeting.
At the meeting, the emphasis was put on the introduction of the principle of "SUA-I HIFU System " and p-HIFU technology, along with the highlight of clinical data recording, the presentation of clinical trial protocol; and the discussion of specific division of work.
President Wang stressed that safety must come first in clinical trials. Any possible problem and solution should be considered in advance. All researchers must complete the clinical work in a standardized, accurate and timely manner with a high sense of responsibility and rigorous attitude.
Professor Bai pointed out that clinical trials required all researchers to work together in many ways, and all problems encountered must be fed back in time. Safety must be ensured during the trail, and the process of data recording should be rigorous and standardized.
All participants said that thanks to the kick-off meeting, they had a deeper understanding of clinical trials and relevant laws and regulations. Also, they clarified the responsibility of research sites in clinical trials, which laid a solid foundation for the follow-up clinical work.