IMPALA Clinical study (EDCTP Study) Malawi
In the summer of 2022 we started our EDCTP study in Malawi. This study is set up in two hospitals in Malawi, namely Queen Elizabeth Central Hospital in Blantyre and Zomba Central Hospital in Zomba.
The goal of this study is to validate the IMPALA monitor, gather data for algorithm development and conduct last clinical tests before Malawian market entry. We planned to do this study for one year, to gather data of around 1000 patients. Following successful development and improvement of the IMPALA system and development of the predictive algorithms in the first phase, these algorithms will be integrated into IMPALA for further pilot testing in the first half of 2024. This in effect will contribute to the GOAL 3 innovation pipeline.
For the start of this study we installed 45 monitors in the two hospitals in Malawi and we gathered a team of motivated people to help us with this study. Before we started with the study we gave all the health workers training about how to work with our monitors and how to help us with collecting data for the study. This study is part of the IMPALA project that started in June 2021. For this study we got an EDCTP grand, which is EU funded and gave us the opportunity to start this study in Malawi.
In the beginning of the study we had to tackle some bottlenecks. Because the whole system is new for the Malawian people, we had to gain a lot of trust from the patient's families to get approval to recruit the patients to the monitor. After a while people got used to our system and the people started to trust it, which gave us the possibilities to set up the study in a good way.