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.
