Zynex Monitoring Solutions recently reported it has started enrolment in a haemodialysis clinical trial with its CM-1500 fluid monitoring system. The study, conducted at DaVita Clinical Research clinics, is aimed at further characterising changes in the device’s patented Relative Index during haemodialysis sessions whereby large volumes of fluid are removed from the patient.
It is expected that the study will complete enrolment in the first quarter of 2022.
Zynex obtained US Food and Drug Administration (FDA) clearance for the CM-1500—a non-invasive system intended to monitor patients’ fluid balance in hospitals and surgical centres—in February 2020.
“Engaging in these trials will not only refine our devices and technology but will also push the monitoring division forward to better serve patients across the world,” said Thomas Sandgaard, Zynex CEO, chairman and founder. “We are excited to take this next step in innovating the clinical value that our technology provides hospitals and surgical centres.”
According to a press release, Zynex expects to initially target operating rooms and surgeries that typically display substantial blood loss, as well as recovery rooms and intensive care units where internal bleedings are more common and difficult to detect until serious complications occur.
The company’s vice president, Donald Gregg, added: “Investing in clinical evidence is critically important to clearly articulate how our device performs in multiple care settings, and the haemodialysis population is of particular interest due to the controlled setting and known volume removed from patients on a regular basis.”