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Article History

Received: 1 July 2024

Accepted: 26 September 2024

First Online: 5 October 2024

Declarations

:

: All investigators involved in this research will conduct this study in accordance with the Declaration of Helsinki and the Ministry of Health, Labour and Welfare of Japan Ethical Guidelines for Clinical Studies. The protocol has been approved by the Wakayama Medical University Hospital Institutional Review Board (approval number 3923) and in the protocol registration system at the University Hospital Medical Information Network Clinical Trials Registry (UMIN000052089). All subjects for this study will be provided with a consent form describing this study and containing sufficient information for them to make an informed decision about their participation in this study. The consent form will be submitted with the protocol for review and approval by the institutional review board for the study.

: Not applicable.

: The study will be funded by Medtronic. All medical costs related to this study will be covered by the health insurance as the routine practice and patients will pay out-of-pocket costs for observations, tests, radiotherapy, and other drugs used during the clinical study.