Bad Hersfeld

Researchers are evaluating the Lifetech Cera4 Vascular Plug System in patients requiring arterial or venous embolization in the peripheral vasculature. This study aims to confirm the device's safety and performance, identify any previously unknown side effects, monitor known side effects related to the procedures or device, and analyze emerging risks. The study will enroll 132 subjects with conditions such as aneurysm, endoleak, pulmonary arteriovenous malformation, portal hypertension, arteriovenous fistula, and splenic laceration. The Cera4 Vascular Plug System includes a self-expandable, cylindrical Ni-Ti wire mesh device and its accessory introducer kit. Participants will receive the device for embolization therapy as needed. This is a multi-center, prospective, observational, single-arm, open-label post-market study conducted under MDR requirements. The enrollment period is estimated to last 1 year, with each participant followed for 1 year after treatment. During the study, participants will undergo evaluations to monitor the device's technical success and safety outcomes. Researchers will collect clinical data throughout the 1-year follow-up to assess performance and identify any side effects or risks related to the device or procedures. The final study report is expected to be completed in 2026, ensuring thorough monitoring and long-term data collection.

Researchers are evaluating a new mechanomyograph device for monitoring neuromuscular block during surgery. This device is compared to the commonly used acceleromyograph, which measures the degree of neuromuscular block in clinical anesthesiology. The study aims to assess if the mechanomyograph can provide more precise measurements and explore different stimulation patterns than the acceleromyograph. The study has two parts: the first part directly compares the mechanomyograph with the acceleromyograph. In the second part, two mechanomyographs using different stimulation patterns are compared. The main intervention involves measuring the time course of neuromuscular block using these devices during surgery requiring general anesthesia and neuromuscular blocking agents. Participants will be monitored from enrollment until the end of anesthesiologic treatment on the day of surgery, which occurs 2 to 3 weeks after enrollment. The primary measure is the difference in time to recovery to a train of four ratio of 1.0. This means researchers will track how quickly the neuromuscular block recovers during the surgical process. The trial includes adults aged 18 to 65 years undergoing surgery with neuromuscular blocking agents.