A pragmatic trial network for intraoperative margin tools, paid on margin reduction
Tools that show surgeons where the tumour ends during the operation could cut the number of patients who need a second operation, but none has been properly tested at scale. A network would run those trials and pay on results.
A standing network of surgical centres running randomised, pragmatic trials of fluorescence-guided surgery agents, intraoperative specimen imaging, optical and mass-spectrometry margin probes and AI-based margin prediction, with positive-margin and re-operation rates as primary endpoints and payer contracts that reimburse devices on demonstrated margin reduction. Several agents and devices are approved or near approval, but adoption is slow because evidence is single-centre and payers are unconvinced. The network would also standardise pathology margin assessment, which varies enough to confound trials.
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