Clinical trials

In clinical studies, independent investigators investigate the effect of a treatment method or a diagnostic method. The aim is to carry out an independent evaluation in order to create evidence for a particular method.

Clinical development studies in progress

In collaboration with NanoEcho, two investigator-led clinical development studies on surgical rectal cancer tissue are ongoing. In June 2021, the first one began at Sahlgrenska University Hospital in Gothenburg under the direction of Professor Eva Angenete. In November 2022, the second one began at Skåne University Hospital in Malmö under the direction of Professor Henrik Thorlacius. Experience and input from these clinical development trials are used to evaluate the system and to support the product development.

Together, these two studies will provide valuable information on system performance – including patients with different tumour positions and different stages of rectal cancer. The studies also provide important information for the design of the upcoming clinical registration trial. The study required to obtain regulatory approval.

Professor Henrik Thorlacius talks about the investigator-led development study at Skåne University Hospital in Malmö.

Scientific evidence for NanoEcho’s imaging method

An image of magnetic nanoparticles in human tissue, which was created with NanoEcho’s prototype system, was shown for the first time in the ongoing investigator-led study at Sahlgrenska University Hospital. The results are now published in a scientifically reviewed article.

I am pleased to see that we have now made some progress in our efforts to improve rectal cancer diagnosis.

Eva Angenete

Professor of Surgery at Sahlgrenska University Hospital

A registration study is planned

In order to obtain market approval for the NanoEcho system, a registration study is required – a clinical trial aimed at obtaining regulatory approval of the system, including the particle, for sale and use in clinical practice. The purpose of the study is to prove that NanoEcho’s system is safe and adds value in rectal cancer diagnostics. With this study, the company creates clinical evidence for the method, which is essential for market success.

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