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. 2022 Jun 22;23:526. doi: 10.1186/s13063-022-06456-w
Trial registration Dutch trial register: NL7945
Date registration 09-08-2019
Trial status We started participant recruitment in September 2020 and we expect to complete the recruitment in November 2022.
Version 2
Sponsor

Medical Center Leeuwarden

8934 AD Leeuwarden

The Netherlands

Phone: +31 58 286 6969
Principal investigator(s) L.J.M. de Heide, MD, Internist-Endocrinologist, Center for Obesity Northern Netherlands (CON)/Medical Center Leeuwarden
Roles and responsibilities

Daily support and coordination of the study is provided by:

Principle investigator: supervision of the study, annual safety reports, and trial registration.

Study coordinator: coordinates study, ensures follow-up according to protocol, reporting Serious Adverse Events (SAE), takes informed consent, organizes data capture and collection, and follow-up of study patients.

Surgeons: identifies potential recruits, explanation of the study, and applying the intervention.

Study physician/physician assistant: explanation of the study, takes informed consent, data collection, and follow-up of study patients.