Efficacy and Safety of a Novel Hemostatic Peptide Solution During Endoscopic Submucosal Dissection: A Multicenter Randomized Controlled Trial.

"CONFLICTS OF INTEREST Guarantor of the article: Toshio Uraoka, MD, PhD. Specific author contributions: T.U.: conception and design, collection, interpretation, and analysis of the data, and drafting of the article. N.U., T.O., Y.S., N.Y., A.F., and Y.K.: collection and interpretation of the data and drafting of the article. K.M., T.H., and Y. Y.: a third-party evaluation committee. All authors reviewed, contributed to, and approved the final version of the manuscript. Financial support: The work was supported by 3-D Matrix. Potential competing interests: 3-D Matrix contracted and paid all hospitals on the basis of good clinical practice. T.U. and H.T. received consulting fees from 3-D Matrix. Y.N. received consulting fees from Olympus, Boston Scientific, Top, and Fuji film. Y.N. is a patent coholder with Olympus, Pentax, and Top. Y.N. reviewed a research grant from Kaigen Pharmaceutical. T.U and H.T. received lecture fees from Olympus Medical and Fujifilm Medical. K.M. received lecture fees from Olympus. N.U. received lecture fees from Olympus, Fujifilm, Boston Scientific Japan, Daiichi-Sankyo, Takeda Pharmaceutical, EA Pharma, Otsuka Pharmaceutical, AstraZeneca, and Miyarisan Pharmaceutical. Y.N. received lecture fees from Olympus, EA Pharma, Takeda Pharmaceuticals, Ostuka Pharmaceuticals, Astra Zeneca, and Daiich-Sankyo. The remaining authors have no relevant conflicts or financial relationships to report. Ethics: This study was conducted with the approval of the Institutional Review Board of each facility in compliance with relevant laws and regulations, including the Declaration of Helsinki and the Ministerial Ordinance on Good Clinical Practice for Medical Devices. Before conducting the study, the principal investigator or subinvestigators explained the details of the study to the patients and obtained their written informed consent. Clinical trial registry: The study was registered in the UMIN clinical trial registration system (Unique ID issued by UMIN: UMIN000042009)."

"Financial support: The work was supported by 3-D Matrix."

"This multicenter, randomized, open-label, parallel-group comparative trial was conducted from August 2017 to August 2019 with the approval of the Institutional Review Board of each facility in compliance with relevant laws and regulations, including the Declaration of Helsinki and the Japanese Ministerial Ordinance on Good Clinical Practice for Medical Devices. The study was registered in the University Hospital Medical Information Network clinical trial registration system (UMIN000042009). Before conducting the study, the principal investigator or subinvestigators explained the details of the study to the patients and obtained their written informed consent."