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Article History

Received: 21 April 2025

Accepted: 5 June 2025

First Online: 2 July 2025

Declarations

:

: Hefei CAS Ion Medical and Technical Devices Co., Ltd. covered the expenses for this clinical study. The Hefei CAS Ion Medical and Technical Devices Co., Ltd. was not directly involved in study design and data analysis. The trial design was jointly discussed and completed by medical experts from the contract research organization conducting the clinical trial and the principal researchers from each center. All data were uploaded to the electronic system in a timely manner after patient follow-up was completed, and a data-analysis team from a third-party company was entrusted with the data for analysis. The scientific research fund project of the Anhui Medical University (No.2022xkj048), Provincial Financial Fund Supported Project of Anhui Provincial Health Commission (AHWJ2024Aa10118), Natural Science Research Project of Colleges and Universities of Anhui Province (No.2023AH053171) played a role in the writing of the manuscript. Jingwen Wang, Ke Xue, Jing Gao, Chengda Yuan, Zebin Meng, Linge Li, Lili He, Chenchen Zhang, Xingyu Yang, Jing Wang, Yongmei Lv, Xin Du, Liyun Wang, Chuyu Fu, Na Wang, Yuyan Cheng, Feng Wang, Qing Li, Tingfang Zhang, Yong Cui and Chunjun Yang declare that they have no competing interest.

: The trial was conducted in accordance with the Declaration of Helsinki, and approved by the Ethics Committees of the Second Affiliated Hospital of Anhui Medical University (SL-QX2021-005; 2021.09.03), China-Japan Friendship Hospital (QX2022-032-01; 2022.11.28), First Affiliated Hospital of Wenzhou Medical University (SL2022-133; 2023.01.16), Hangzhou Traditional Chinese Medicine Hospital (2023LL024; 2023.09.15); and Shijiazhuang Traditional Chinese Medicine Hospital (23/09/01-01; 2023.09.28). Its design, implementation, and reporting adhered to the Good Clinical Practice guidelines for medical device clinical trials, Helsinki Declaration (2013), relevant regulations from the National Medical Products Administration, and ethical committee recommendations. The study protocol, electronic case report form, informed consent form, and other written materials provided to the participants were approved by the ethics committees at each participating hospital. Before initiating any study-specific procedures, all patients were required to sign informed consent forms. The sponsor (Hefei CAS Ion Medical and Technical Devices Co., Ltd., Hefei, China) and principal investigators were responsible for the design and conduct of the study. This study has been registered at (ChiCTR2300069993).