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Pre-clinical study on a telemetric gastric sensor for recognition of acute upper gastrointestinal bleeding: the “HemoPill monitor”

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.

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Author information

Correspondence to Sebastian Schostek.

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Disclosures

Sebastian Schostek, Thomas Gottwald and Marc O. Schurr hold management positions with Ovesco Endoscopy AG. Melanie Zimmermann, Jan Keller, Mario Fode, Michael Melbert are employees of Ovesco Endoscopy AG. Ovesco Endoscopy AG received grants from the European Commission (project title “Versatile Endoscopic Capsule for gastrointestinal TumOr Recognition and therapy Contract”; grant number: 033970) and the German Federal Ministry BMWI (project title “Miniaturisierte Funkschnittstelle zur zuverlässigen drahtlosen Datenübertragung aus dem menschlichen Körper”; grant number EP120781). Ruediger L. Prosst has no conflict of interest.

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Schostek, S., Zimmermann, M., Keller, J. et al. Pre-clinical study on a telemetric gastric sensor for recognition of acute upper gastrointestinal bleeding: the “HemoPill monitor”. Surg Endosc 34, 888–898 (2020) doi:10.1007/s00464-019-06845-4

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Keywords

  • Acute upper gastrointestinal bleeding
  • Bleeding detection
  • Gastric implant
  • Blood sensor
  • Pre-clinical study