In order to register and approve medical devices, a lot of globally different requirements have to be met. However, one uniform requirement around the world is having proof that the product is safe to use for patients, users and third parties. To evaluate the products, validations are usually based on empirical data conducted in clinical or pre-clinical studies. However, empirical studies bring certain disadvantages with them. They are difficult to conduct, expensive and involve tests on humans. The overall goal is to reduce the need for clinical trials through validated models. In this project, high frequency (HF) surgery as a surgical technique is being investigated in collaboration with KARL STORZ SE & Co. KG to achieve this goal. The emphasis will be placed on laparoscopic procedures as they are known to cause less blood loss as well as shorter recovery time and therefore shorter hospitalization time. Even though the usage of electromedical devices is well established, proof for the effectiveness and efficiency of HF generators and device parts is still insufficient. Specific (technical) settings for these devices in the operating room are still based on experience and tradition.
Together with our industry partner, we aim to determine the effectiveness of different settings and configurations based on the type of tissue and type of operation in HF surgery. To prove effectiveness, certain postoperative data can be collected and compared by conducting a meta-analysis. Correlations between tissue type (physiological parameters) and generator mode (technical parameters) will be investigated. Physiological and statistical modeling will be used to establish scientific correlations between electrical energy input and tissue response to predict tissue response in a biological/clinical context.
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Prof. Dr. rer. nat. Knut Möller
Telefon: +49 (0) 7720 307-4390
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