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Article History

Received: 27 January 2021

Accepted: 13 May 2021

First Online: 22 May 2021

Declarations

:

: The study protocol was approved by the local institutional review board (IRB) or ethics committee (EC) of all six participating medical centers. Dept. of Gastroenterology and Hepatology, University Medical Center Mainz, Mainz, Germany (Ethik-Kommission bei der Landesarztekammer Rheinland-Pfalz); Division of Gastroenterology and Hepatology, New York University Langone Medical Center, New York City, NY, USA. (NYU School of Medicine Office of Science and Research Institutional Review Board); Division of Gastroenterology, Washington University in St. Louis, St. Louis, MO, USA. (Washington University in St. Louis Human Research Protection Office); Division of Gastroenterology and Hepatology, Department of Medicine, University of California, Irvine, Orange, CA, USA. (University of California, Irvine Office of Research: Institutional Review Board); Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA. (Mayo Clinic Institutional Review Board); Division of Gastroenterology, Valley Hospital, Ridgewood, NJ, USA. (Western Institutional Review Board).Written informed consents from individual subjects were also obtained. The study was performed in compliance with the Declaration of Helsinki and registered on ClinicalTrials.gov (NCT03503162; first posted on 19/04/2018).

: Not applicable.

: H.N., V.K., M.L.J.S. provided user feedback on next generation device development (this manuscript reports results of earlier generation product). S.G. is an advisor to Motus GI Holdings, Inc.