The ECTUL is a central early clinical trial unit for the conduct of phase-I/II clinical trials, including First-in-Human clinical trials. Primary goal is to evaluate the safety, tolerability and efficacy of new investigational therapies. The ECTUL is open to all medical departments of the University Hospital Leipzig as well as the cooperating partners and offers innovative therapeutic options for patients.
Due to the ECTUL translational research possibilities are multiplied at the University Hospital Leipzig. It provides a platform for innovative medicine in an interdisciplinary setting.
We use an electronic data management system for documentation and organization of treatment appointments for all patients enabling an optimal link between in- and outpatient treatment.
The ECTUL consists of two double rooms equipped with bed-side monitoring to comply with regulatory guidelines of European and German authorities for First-in-Human trials. It is possible to centrally monitor and control cardiac functions and other vital parameters to accommodate safety assessments and measures.
We are currently providing two rooms for patient treatment comprising two intensive care beds in each room with intensive care monitoring, separate bathroom, WLAN- and TV-services. Two additional rooms will be expanded in near future, thus providing eight beds. To ensure an optimal inpatient treatment the rooms are integrated in the stationary hematologic care offering 24 hours / 7 days medical surveillance and specialized nurse care. The ECTUL is localized next to the intensive care unit to assure immediate emergency measures as needed. In addition, relevant examining departments are localized within the building, such as cardiology, radiology and pulmonology. A 24 hours / 7 days emergency hotline guarantees rapid assistance for ambulatory patients in need.
Furthermore, room for storage of study documents and samples as well as processing of trial samples with calibrated and certified devices like centrifuge, freezer and fridge is available within the ward. The fridge (4°C) and freezer (-20°C and -80°C) are connected to a central surveillance system and emergency power system.
For the visit of monitors and auditors various rooms equipped with computer, WLAN and printers are available.