Magle Group launches multicenter trial with pancreatic leakage indicator
Magle Group has partnered with Heidelberg University Hospital in Germany to launch a study evaluating the effectiveness of SmartPAN in pancreatic surgery. This post-market study aims to further explore SmartPAN’s ability to detect and prevent pancreatic fluid leakage following surgical procedures.
– We are pleased to share the progress of SmartPAN, and continue to establish the first-in-class medical device in the market, says Helena Ossmer Thedius, Chief Marketing & Innovation Officer of Magle Group.
SmartPAN serves as biochemical leakage indicator, aiding surgeons in visualizing pancreatic fluid leaks and ensuring complete tissue closure during procedures. SmartPAN is based on Magle Group’s proprietary polymer technology, DSM (Degradable Starch Microsphere), and loaded with the pH indicator bromothymol blue (BTB).
BTB has an orange color in neutral or acidic environments and turns blue in alkaline media, such as pancreatic fluid. This color change enables surgeons to detect and localise pancreatic leakage. Classified as a medical device, BTB is CE-marked, allowing it to be marketed within the EU.
Post-market study with Heidelberg University Hospital
Magle Group is launching a post-market clinical follow-up study to assess SmartPAN’s effectiveness in detecting and preventing intraoperative pancreatic leaks, aiming to reduce the incidence of postoperative pancreatic fistula (POPF) – one of the most serious complications following pancreatic surgery.
Patient recruitment is set to begin in March 2025, with a focus on individuals undergoing distal pancreatectomy. The study will enrol 100 patients over a two-year period across three European hospitals, including Heidelberg University Hospital.
Aimed at reducing postoperative complications
Pancreatic surgery is known for its high complication rates, making innovative solutions like SmartPAN essential:
– Post-operative complications still affects a reasonable number of pancreatic surgeries. In this context, SmartPAN, which is developed by our group in collaboration with Magle Chemoswed, represents a promising technological advancement, says principal investigator PD Dr. med. Thomas Pausch, MD.
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