Clinical studies – EndoDrill® Model X
In the autumn of 2020, the first clinical study was initiated at three Swedish university hospitals (EDMX01) for sampling of suspected cancer in the stomach (SEL). In the study, which includes 20 patients, comparative samples are collected from each patient using both EndoDrill® Model X and the leading competing fine needle instruments (EUS-FNB). The primary endpoint is to show that EndoDrill® Model X is a safe method for ultrasound-guided sampling. The secondary endpoint involves an evaluation of how much tissue EndoDrill® Model X can take compared to standard biopsy needles. The study is expected to be completed in 2021.
A Swedish pilot clinical study (n=10) started in Q1-21 for deep tumour sampling with EndoDrill® Model X in muscle invasive bladder cancer. The study is expected to be completed in 2021.