Novel telemetric sensor capsule for EGD urgency triage: a feasibility study

Arthur Schmidt, Melanie Zimmermann, Markus Bauder, Armin Kuellmer, Karel Caca, Arthur Schmidt, Melanie Zimmermann, Markus Bauder, Armin Kuellmer, Karel Caca

Abstract

Background and study aims Upper gastrointestinal bleeding (UGIB) is a frequent cause of hospitalization. Because of the lack of reliable noninvasive diagnostic tools, the decision to proceed with emergency endoscopy in these cases is made based on clinical parameters. A novel non-imaging telemetric real-time sensor capsule (HemoPill Acute, Ovesco Endoscopy AG) has shown promising results for noninvasive detection of UGIB in preclinical studies. Patients and methods We conducted a prospective non-randomized, single center, open-label study to investigate feasibility and safety of the novel sensor capsule in patients with symptoms of UGIB. The primary aim of the first clinical study was to investigate feasibility and safety of the device in a clinical setting. All patients underwent endoscopy within 12 hours after capsule ingestion. Sensor data from the capsule within 10 minutes after ingestion were compared with endoscopic findings. Results From April 2015 to February 2016, 30 consecutive patients with symptoms of acute UGIB were included; 27 were eligible for analysis. Capsule ingestion was well tolerated in all patients and there were no device-related adverse events. Endoscopy showed blood or hematin in the upper gastrointestinal tract of 10 of 27 patients; in 2 of 10 patients it was estimated to be more than 20 mL; in 4 of 8 patients it was between 5 and 20 mL and in 4 of 8 it was estimated to < 5 mL. The sensor capsule was positive in 2 of 2 patients (100 %) with > 20 mL of blood or hematin and in 1 of 8 patients (12.5 %) between 5 and 20 mL. All patients (17/17; 100 %) were correctly identified as non-bleeders. Conclusion Both device and procedure proved to be safe and feasible. Larger studies will be necessary to evaluate the role of the sensor capsule in risk stratification of patients with acute UGIB.

Conflict of interest statement

Competing interests Klinikum Ludwigsburg received study grants from Ovesco Endoscopy. Dr. Schmidt and Prof. Caca received lecture fees from Ovesco Endoscopy. Ms. Zimmermann is working as Project Manager at Ovesco Endoscopy AG and is a PhD candidate at the Eberhard-Karls-University of Tuebingen focusing on the technical and clinical development of the novel innovative sensor capsule.

Figures

Fig. 1
Fig. 1
Sensor capsule. Dimension of the capsule: 7.0 × 26.3 mm.ALED.BMeasuring slot.CPhototransistor. (Source: Ovesco Endoscopy AG)
Fig. 2
Fig. 2
A typical sensor capsule signal (one dot in a graph) in two patients within the first 10 minutes after capsule ingestion. Red line shows the threshold for blood detection. Left: quotient rises above the threshold (> 100), indicating presence of blood. Right: quotient is

Fig. 3

Illustration showing sequence of procedures…

Fig. 3

Illustration showing sequence of procedures during the study. (Source: Ovesco Endoscopy AG)

Fig. 3
Illustration showing sequence of procedures during the study. (Source: Ovesco Endoscopy AG)

Fig. 4

Flowchart showing recruitment of patients…

Fig. 4

Flowchart showing recruitment of patients and correlation of sensor signals with endoscopic findings.

Fig. 4
Flowchart showing recruitment of patients and correlation of sensor signals with endoscopic findings.

Fig. 5

Endoscopic findings of patients with…

Fig. 5

Endoscopic findings of patients with bleeding signs and estimated amount of intraluminal blood…

Fig. 5
Endoscopic findings of patients with bleeding signs and estimated amount of intraluminal blood
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References
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Fig. 3
Fig. 3
Illustration showing sequence of procedures during the study. (Source: Ovesco Endoscopy AG)
Fig. 4
Fig. 4
Flowchart showing recruitment of patients and correlation of sensor signals with endoscopic findings.
Fig. 5
Fig. 5
Endoscopic findings of patients with bleeding signs and estimated amount of intraluminal blood

References

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