Telemetric capsule-based upper gastrointestinal tract – blood detection – first multicentric experience

Abstract

Introduction

Risk stratification in upper gastrointestinal bleeding (UGIB) currently relies on clinical parameters and risk scores. HemoPill^® acute (Ovesco Endoscopy, Tuebingen, Germany) is a pill-shaped, orally administered sensor capsule for real-time blood detection. The aim of this study was to evaluate the system in clinical routine.

Material and methods

Sixty-one consecutive patients in whom the HemoPill^® had been used at 12 international hospitals between July 2019 and March 2020 were retrospectively analysed. Indications for application were the clinical suspicion of UGIB, small bowel bleeding, of rebleeding after hemostasis. Primary endpoints were technical success and bleeding detection/exclusion. Secondary endpoints included adverse events and change of clinical course.

Results

The capsule was used in 45 (73%) patients with UGIB, in 12 (20%) patients with small bowel bleeding and in four (7%) patients for exclusion of rebleeding. Technical success was 98%. 35/60 (58%) cases were capsule-positive and among these, endoscopy showed bleeding in 20/35 (57%) cases. None of the 25 capsule-negative patients rebled. Emergency endoscopy could be avoided in 18/25 (72%) cases. Serious adverse events did not occur.

Conclusion

HemoPill^®-based blood detection is feasible and safe. Negative capsule results might ‘downgrade’ the need for urgent endoscopy.

Keywords:

• Gastrointestinal hemorrhage
• melena
• capsule endoscopy
• gastroscopy
• retrospective studies
• risk assessment

Acknowledgements

Ethical vote. We like to thank the ethics committee of the Medical Board Berlin for granting this retrospective study an ethical vote on December 23rd of 2020. There have been raised no fundamental ethical or legal concerns about this project.

Declaration of interest

We like to thank the manufacturer of the HemoPill^® acute, Ovesco Endoscopy AG, that has provided the HemoPill^® Receiver and the HemoPill^® capsules free of charge. Furthermore the company has paid travel expenses for the author’s personal meeting and consultation at the company headquarter in Tuebingen/Germany. In addition the costs of the ethical vote were paid for by the Ovesco Endoscopy AG.

Among the authors Prof. Alexander Meining is active as consultant for the Ovesco Endoscopy AG, PD Dr. Arthur Schmidt has received lecture fee and study funding.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.