Sebastian Schostek1, Melanie Zimmermann2,3, Jan Keller2, Mario Fode2, Michael Melbert2, Ruediger L Prosst4, Thomas Gottwald2,3, Marc O Schurr2,5. 1. Ovesco Endoscopy AG, Tuebingen, Germany. sebastian.schostek@ovesco.com. 2. Ovesco Endoscopy AG, Tuebingen, Germany. 3. Eberhard Karls Universitaet Tuebingen, Tuebingen, Germany. 4. St. Anna Klinik and Proctological Institute Stuttgart, Stuttgart, Germany. 5. Steinbeis University Berlin, IHCI Institute, Tuebingen, Germany.
Abstract
BACKGROUND: Acute upper gastrointestinal bleeding is a life-threatening medical condition with a relevant risk of re-bleeding even after initial endoscopic hemostasis. The implantable HemoPill monitor contains a novel telemetric sensor to optically detect blood in the stomach allowing the surveillance of high-risk patients for re-bleedings. METHODS: In this pre-clinical porcine study, bleeding has been simulated by injecting porcine blood into the stomach of a pig through an implanted catheter using a syringe pump. The effect of the sensor position in the stomach, the gastric food content, and the bleeding intensity was investigated. RESULTS: Sensitivity and specificity of the sensor reached more than 87.5% when the sensor was positioned close to the source of bleeding. Solid food had a higher negative impact on sensitivity than liquid food but a positive impact on specificity. A heavy bleeding was more likely to be detected by the sensor but was also associated with a lower likelihood for true-negative results than weaker bleedings. CONCLUSIONS: The study clearly demonstrated the capability of the HemoPill sensor prototype to detect clinically relevant bleedings with high sensitivity and specificity (> 80%) when the sensor was positioned close to the bleeding site. The sensors proved to be robust against artefact effects from stomach content. These are favorable findings that underline the potential benefit for the use of the HemoPill sensor in monitoring patients with a risk of re-bleeding in the upper gastrointestinal tract.
BACKGROUND:Acute upper gastrointestinal bleeding is a life-threatening medical condition with a relevant risk of re-bleeding even after initial endoscopic hemostasis. The implantable HemoPill monitor contains a novel telemetric sensor to optically detect blood in the stomach allowing the surveillance of high-risk patients for re-bleedings. METHODS: In this pre-clinical porcine study, bleeding has been simulated by injecting porcine blood into the stomach of a pig through an implanted catheter using a syringe pump. The effect of the sensor position in the stomach, the gastric food content, and the bleeding intensity was investigated. RESULTS: Sensitivity and specificity of the sensor reached more than 87.5% when the sensor was positioned close to the source of bleeding. Solid food had a higher negative impact on sensitivity than liquid food but a positive impact on specificity. A heavy bleeding was more likely to be detected by the sensor but was also associated with a lower likelihood for true-negative results than weaker bleedings. CONCLUSIONS: The study clearly demonstrated the capability of the HemoPill sensor prototype to detect clinically relevant bleedings with high sensitivity and specificity (> 80%) when the sensor was positioned close to the bleeding site. The sensors proved to be robust against artefact effects from stomach content. These are favorable findings that underline the potential benefit for the use of the HemoPill sensor in monitoring patients with a risk of re-bleeding in the upper gastrointestinal tract.
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