Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (01EE1404B)
Received: 18 May 2018
Accepted: 11 October 2018
First Online: 26 October 2018
Ethics approval and consent to participate
: This trial has been approved by the Ethics Committee of the Technical University Dresden (central ethics committee, DE/EKSN38) and the local ethic committees of the participating trial centers (DE/EKBE14, DE/EKHE18, DE/EKHH17, DE/EKNW28). The Ethics Committee will be notified of any amendment to the study protocol.Aims, procedures and design of the study are comprehensively explained to eligible patients, written informed consent is required prior to enrollment of all participating patients. In case of any amendment to the study protocol, all patients enrolled provide modified written informed consent regarding the amendments. All patients can withdraw previously provided consent at any time without specification of reasons and without any adverse or disadvantageous consequences.A Data Monitoring (Safety) Committee (DMSC) is not needed. This clinical trial conforms to the requirements of the MDR (Medical Device Regulation). As the medical device itself is expected to have a low safety risk it is exempt from the approval of the higher federal authorities. For the same reason, no interim analysis or stopping guidelines are installed. Collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct will be performed according to the MDR. If deemed necessary, audits can be arranged by the sponsor. Two different types of insurance are provided to all participants to compensate for those who suffer harm from trial participation. One insurance will cover harms that may happen on the way to study appointments and back home respectively. The other insurance will cover for harms directly associated with study procedures.
: Not applicable.
: The authors declare that they have no competing interests.
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