Document is current

Article History

Received: 15 December 2022

Accepted: 15 May 2023

First Online: 24 May 2023

Declarations

:

: The study protocol has been approved by the institutional review board at The University of Tokyo Hospital (Tokyo, Japan; # 2021005P) and each collaborating centre. Written informed consent will be obtained from all potential participants. The study was designed and implemented according to the guidelines in the Helsinki Declaration.

: n/a. In the present trial, we do not plan to describe any details or use images/videos of an individual participant. In case that those data will be required for publication, written informed consent for the publication will be obtained from that person. We will be willing to provide a model consent form on request.

: H.I. declares research funding from Boston Scientific Japan, Fujifilm, and Piolax Medical Devices; honoraria from Boston Scientific Japan, Century Medical, Create Medic, Fujifilm, Gadelius Medical, Hitachi Medical, Japan Lifeline, Kaneka, Kawasumi Laboratories, Olympus Medical, Piolax Medical Devices, Sumitomo Bakelite, UMIDAS, and Zeon Medical; and contributions from Boston Scientific Japan, Gadelius Medical, Japan Lifeline, and Zeon Medical. Y.N. declares research funding from Boston Scientific Japan, Century Medical, Fujifilm, Gadelius Medical, HOYA Pentax Medical, Hitachi Medical, Kaneka, and Medico’s Hirata; and honoraria from Boston Scientific Japan, Fujifilm, Gadelius Medical, Hitachi Medical, J-MIT, Medico’s Hirata, and Olympus Medical. This work was not supported by any of those companies. The other authors declare no conflicts of interest related to this article.