Bad Hersfeld

This research aims to collect and assess clinical data on patients using the Lifetech Cera Vascular Plug System, a device designed for arterial and venous embolization in the peripheral vasculature. The studys purpose is to confirm the safety and performance of this device, identify any previously unknown side effects, monitor known side effects related to the device or procedures, and analyze emerging risks associated with its use. Participants will receive treatment with the Cera Vascular Plug System, which includes a self-expandable cylindrical Ni-Ti wire mesh plug and an accessory introducer kit. The study is observational and single-arm, enrolling patients who require arterial or venous embolization in the peripheral blood vessels. Each participant will be followed for approximately one year after the procedure to monitor outcomes and any device-related events. During the study, participants will undergo evaluations to measure technical success at the time of the procedure and follow-up assessments at 3, 6, and 12 months to detect clinically relevant recanalization and migration. Researchers will also monitor adverse events, serious adverse events, and device deficiencies throughout the year. The study includes various clinical visits and assessments to ensure thorough safety and performance monitoring over the total participation period of one year.

Researchers are evaluating a new device that uses mechanomyography to assess the degree of neuromuscular block during surgery. This method has been mostly experimental until now and may provide more precise measurements compared to the commonly used acceleromyography. The study aims to compare these two devices and their different stimulation patterns to improve monitoring during anesthesia. The study is divided into two parts. The first part directly compares the new mechanomyograph device with an acceleromyograph. The second part compares two mechanomyographs using different stimulation techniques. Participants will undergo neuromuscular block monitoring during their surgery using these devices. Participants scheduled for surgery under general anesthesia with neuromuscular blocking agents will be involved. Researchers will measure the time it takes for recovery to a specific train of four ratio from enrollment until the end of anesthesiologic treatment on the day of surgery, which occurs 2 to 3 weeks after enrollment. This helps assess the accuracy and timing of neuromuscular recovery. The study lasts from enrollment until the end of the anesthesiologic treatment on the surgery day.