RCT Trial Exploring Efficacy of PuraStat® in EMR Surgeries Goes Live
The clinical trial ‘Colorectal EMR & Delayed Bleeding: Prospective multicentre randomised controlled superiority trial comparing PuraStat® with conventional practice to reduce the risk of delayed bleeding after colorectal EMR in high-risk patients’ (COLOSTAT Trial), is now live at the lead site - Queen Alexander Hospital, Portsmouth.
The trial, funded by 3-D Matrix, is led by the Chief Investigator Prof. Pradeep Bhandari MD, MRCP, from the sponsor Queen Alexandra Hospital (and is now open to recruitment). The intention is to open up to 10 sites, across the UK and Italy, with recruitment planned for 18 months.
Delayed bleeding is a common complication following EMR, occurring in 3-12%. There are no established guidelines surrounding reducing the risk of delayed bleeding following EMR. Clip closure may be utilised, however, it can be technically challenging.
A recent randomised trial, while showing statistically significant reductions in delayed bleeding with complete clip closure, also showed that complete closure was only possible in 57% of cases. This demonstrates the unmet need in clinical practice surrounding delayed bleeding in high risk colonic EMR. PuraStat is currently indicated for delayed bleed reduction following colonic endoscopic submucosal dissection (ESD), making it a strong candidate to potentially meet this unmet clinical need.