PeriSaFe01 – a multicenter trial evaluating PERIsign, a device that objectively detects peritonitis in patients with acute abdominal pain

Abstract Introduction Acute abdominal pain (AAP) is a common complaint in the ER, seldom requiring urgent care, but diagnosing can be challenging and advanced imaging overused. With the aim of improving the assessment of AAP, we evaluated a new medical device - PERIsignTM, that objectively, non-invasively and quickly demonstrates peritonitis in patients with AAP. Method This was a proof-of-principle, open, multi-center investigation. 20 healthy volunteers and 20 patients with suspected appendicitis, planned for emergency surgery, were evaluated with PERIsign. In the PERIsign monitor; graphical curves of muscle activity as well as palpation stimuli were observed and evaluated by tree blinded physicians. The primary endpoint was to evaluate the safety of PERIsign, the secondary endpoint was diagnostic accuracy. In subgroup analysis the study participants were divided into tertiles based on their BMI. Result Only three adverse events and no severe adverse events were reported. Sensitivity and specificity for appendicitis were reported in a majority vote as 80 % and 70 % in all patients combined, respectively. In the BMI medium group, the sensitivity was 100% and specificity 80%. Discussion In this study, PERIsign was shown to be safe and effective in patients with suspected appendicitis, demonstrating diagnostic accuracy comparable to ultrasound. As safety was the primary endpoint and the sample size was limited, definitive conclusions regarding accuracy cannot be drawn. However, technical refinements in signal processing and AI integration applied to the collected data indicate promising potential for improved diagnostic performance.