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. |