Clinical studies – EndoDrill®
Upper GI – COMPLETED
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® GI and the leading competing fine needle instruments (EUS-FNB). The primary endpoint is to show that EndoDrill® GI is a safe method for ultrasound-guided sampling. The secondary endpoint involves an evaluation of how much tissue EndoDrill® GI can take compared to standard biopsy needles.
The study was completed earlier than expected in November 2021 after an interim analysis showed that the objective of the study has been achieved already in seven out of the planned 20 patients. Preliminary results indicate that the product safely enables effective sampling of core biopsies when examined with endoscopic ultrasound. The next step is to prepare for a scientific publication.
The results of the study were presented at a poster session at the DDW Congress in San Diego on May 21, 2022.
Urinary Bladder – COMPLETED
A Swedish pilot clinical study (n=10) started in Q1-21 for deep tumour sampling with EndoDrill® URO in muscle invasive bladder cancer. The study was completed in July 2022 and scientifically published in the European Urology Open Science in June 2023. The study shows that EndoDrill® URO safely can take treatment-deciding tissue samples earlier in the diagnostic work-up in case of suspicion of cancer in the urinary bladder. The research group concludes that it is now warranted to follow up the pilot study with a randomized efficacy study, which is already planned and regulatory approved.